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Archived medical countermeasure-related news from the FDA Office of Counterterrorism and Emerging Threats (OCET), Medical Countermeasures Initiative (MCMi) and federal partners. Also see our events archive.

Current news & events

2023 | 2022 | 2021 and earlier

2023

• January 25, 2023: MCMi email - Developers of drug and biological products for mpox: new draft guidance | Jan. 26 VRBPAC viewing info

• January 20, 2023: FDA issued an immediately-in-effect guidance on compounding certain ibuprofen products in an effort to bolster supply of pediatric ibuprofen amid record high demand. The guidance clarifies FDA’s regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems.

• January 19, 2023: FDA announced availability of a draft guidance for industry: Mpox: Development of Drugs and Biological Products. FDA is issuing this guidance to support sponsors in their development of drugs and biological products for mpox. This guidance provides nonclinical, virology, and clinical considerations for mpox drug and biological product development programs, with a focus on recommendations to support initiation of clinical trials. Preventive vaccines are not addressed in this guidance. Submit comments by March 21, 2023. 

• January 18, 2023: MCMi email - Regulatory science funding deadline reminder | COVID-19 and mpox updates from FDA

• January 13, 2023: CDC and FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older - No change in vaccination practice is recommended. Also see: COVID-19 Vaccine Safety Surveillance

• January 12, 2023: FDA made minor updates to two COVID-19 testing guidances to help ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways. The updated guidances are:

  • Policy for Coronavirus Disease-2019 Tests (Revised); and

  • Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised).

  The minor updates to these guidances reflect FDA’s intent for the two guidances to remain in effect for the duration of the declaration under section 564 of the Federal Food, Drug, and Cosmetic Act that circumstances exist justifying Emergency Use Authorization (EUA) of in vitro diagnostics for the detection of COVID-19, rather than the duration of the public health emergency determination under section 319 of the Public Health Service Act relating to COVID-19. FDA also made minor edits to the Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests guidance to reflect current information about variants and actions the FDA has taken since the original issuance of this guidance.

• January 11, 2023: MCMi email - COVID-19 variant updates | Pediatric disease modeling for long COVID

• January 10, 2023: FDA issued an EUA (PDF, 296 KB) to DiaCarta, Inc. for the QuantiVirus MPXV Test Kit for the qualitative detection of DNA from monkeypox [mpox] virus in human lesion swab specimens from individuals suspected of mpox by their health care provider. Emergency use of this test is limited to authorized laboratories. Learn more: Monkeypox (mpox) Emergency Use Authorizations for Medical Devices

• January 10, 2023: Pediatric disease modeling for long COVID - In an MCMi Regulatory Science program extramural research project, Children’s Hospital Los Angeles and partners are studying how early inflammatory and tissue responses can predict long-term health consequences of COVID-19 in children. 

• January 6, 2023: FDA posted an update that the agency is closely monitoring the emergence of the XBB.1.5 subvariant, a SARS-CoV-2 omicron variant that is currently estimated to account for 27% of circulating variants in the U.S. Because of its similarity to variants that are not neutralized by Evusheld (e.g., XBB), FDA does not anticipate that Evusheld will neutralize XBB.1.5. This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. However, we are awaiting additional data to verify that Evusheld is not active against XBB.1.5. We will provide further updates as new information becomes available.

  Health care providers should inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 variants not neutralized by Evusheld. If signs and symptoms of COVID-19 occur, advise individuals to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate. 

• January 4, 2023: MCMi email - FDA approves treatment for certain hospitalized adults with COVID-19

2022

• December 29, 2022: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to add the DxTerity SARS-CoV-2 RT PCR CE Test as a test expected to have reduced performance for the SARS-CoV-2 omicron variant and sub-variants.

• December 28, 2022: FDA approved a BLA (1.1 MB) for NexoBrid (anacaulase-bcdb) gel, submitted by MediWound, Ltd, Yavne, Israel. NexoBrid is indicated for eschar removal in adults with deep partial thickness and/or full thickness thermal burns.

• December 23, 2022: FDA issued an EUA (PDF, 399 KB) to Beckton, Dickinson and Company for the VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System for the qualitative detection of DNA from monkeypox virus in human lesion swab specimens from individuals suspected of mpox by their health care provider. Emergency use of this test is limited to authorized laboratories. Learn more: Monkeypox (mpox) Emergency Use Authorizations for Medical Devices

• December 22, 2022: FDA granted an extension (PDF, 204 KB) of the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps). Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown here, as long as approved storage conditions noted in the updated fact sheet for health care providers (PDF, 1.3 MB) have been maintained.

• December 21, 2022: FDA approved a new indication for Actemra (tocilizumab) injection (PDF, 2.6 MB) for the treatment of hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). FDA first issued an EUA for Actemra in hospitalized adult and pediatric patients (2 years of age and older) for the same use on June 24, 2021. Actemra remains authorized for emergency use for the same indication for hospitalized pediatric patients 2 to less than 18 years of age who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. FDA has revised the Letter of Authorization (PDF, 249 KB) and associated fact sheets to remove the population covered under the approved indication. Common side effects of Actemra and the recommended dosage for the approved population are included in the prescribing information (PDF, 2.6 MB). Also see: Revised FAQs on EUA for Actemra for Treatment of COVID-19 (PDF, 173 KB)

• December 21, 2022: HHS Increases Access to Tamiflu through the Strategic National Stockpile (from HHS) - HHS/ASPR announced that they are making additional supply of Tamiflu available to jurisdictions to respond to an increased demand for the antiviral during this flu season, including through the Strategic National Stockpile (SNS). Jurisdictions will work with their ASPR Regional Teams to evaluate any requests for Tamiflu through the SNS, ensuring that states, territories, and tribes receive the assistance they need without affecting our nation’s preparedness for a future pandemic flu. Also see from ASPR: Improving Access to Influenza Countermeasures for U.S. Jurisdictions, and from FDA: Expiration Dating Extension - Antivirals 

• December 21, 2022: MCMi email - Vaccine advisory committee meeting on future of COVID-19 vaccines | Understanding at-home OTC COVID-19 antigen diagnostic test results

• December 19, 2022: FDA and Federal Partners Issue Request for Information on the Regulation of Biotechnology - The White House Office of Science and Technology Policy (OSTP) — in coordination with FDA, EPA, and USDA — announced a request for information related to the Coordinated Framework for the Regulation of Biotechnology; comments close February 3, 2023. This action requests relevant data and information to help identify regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology. The request for information seeks case studies and other data that relate to new and emerging biotechnology products. The information provided will help regulatory agencies improve the clarity and efficiency of the regulatory processes for biotechnology products, as described in Executive Order 14081, “Advancing Biomanufacturing and Biotechnology Innovation for a Sustainable, Safe, and Secure Bioeconomy.” OSTP, FDA, EPA, and USDA will hold a virtual listening session on January 12, 2023 (1:00 p.m. ET). To learn how the FDA, EPA, and USDA will work together to implement Executive Order 14081, visit the Unified Website for Biotechnology Regulation.
  
  OSTP also published a request for information on the National Biotechnology and Biomanufacturing Initiative, seeking public input on how advances in biotechnology and biomanufacturing can help achieve goals that were previously out of reach and what steps can be taken to ensure the U.S. has the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. Comments close January 20, 2023.

• December 16, 2022: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19 - On January 26, 2023, FDA will hold a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to consider whether and how the composition for primary doses of the currently available COVID-19 vaccines should be modified and how and whether the composition and schedule for booster doses should be adjusted moving forward. 

• December 16, 2022: FDA’s Center for Veterinary Medicine released a draft update to guidance for industry (GFI) #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.” The guidance is a tool for assessing the risk of antimicrobial resistance (AMR) in people, which could result from the use of a medically important antimicrobial drug in food-producing animals. The scope and purpose of updated GFI #152 remains the same as the initial version of the guidance issued in 2003, but updates better align with current science and clinical practices in human medicine. The agency will be accepting public comments on the draft guidance until March 20, 2023.

• December 14, 2022: New web page: Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results - FDA is providing an easy step-by-step guide to help you decide when and how many times to test for COVID-19, what your test results mean, and what you should do next. FDA-authorized over-the-counter (OTC) at-home COVID-19 tests for self-testing at home or other locations are a fast and convenient COVID-19 testing option.

• December 14, 2022: MCMi email - FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age | Join EMA & FDA for a Dec. 15 mAb workshop

• December 13, 2022: FDA issued an EUA (PDF, 260 KB) to Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.) for the TaqPath Monkeypox/Orthopox Virus DNA Kit, for qualitative detection of DNA from monkeypox (mpox) virus (clade I/II) in human lesion swab specimens from individuals suspected of mpox by their health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests. For more information, see: Individual EUAs for Molecular Diagnostic Tests for Monkeypox

• December 13, 2022: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to add Luminostics, Inc. Clip COVID Rapid Antigen Test as a test expected to have reduced performance for the SARS-CoV-2 omicron variant and sub-Variants.

• December 12, 2022: FDA updated the device shortage list to remove medical gloves (product codes LYY, LYZ, LZA, and LZC). FDA will continue to monitor the supply chain and update the device shortage list and device discontinuance list as new information becomes available. Also see: Medical Gloves for COVID-19

• December 8, 2022: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age - FDA amended the EUAs of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. 

• December 8, 2022: Voluntary Recall of Three Detect Covid-19 Test Lots - Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test, a molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes COVID-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26, 2022 through August 26, 2022. There is an increased chance that the tests from certain lot numbers may give false negative results.

• December 7, 2022: MCMi email - FDA approves first fecal microbiota product | COVID-19 therapeutic EUA updates

• December 6, 2022: FDA issued an EUA for the Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit, a test kit supported by the U.S. Government through the Biomedical Advanced Research and Development Authority (BARDA). The Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating a recent or prior infection, and should not be used to diagnose or exclude an acute SARS-CoV-2 infection.

• December 5, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld, from 18 months to 30 months. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 here).  This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 694 KB) and the EUA Letter of Authorization (PDF, 293 KB).

• November 30, 2022: FDA Announces Bebtelovimab is Not Currently Authorized in Any U.S. Region - FDA announced that bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize omicron subvariants BQ.1 and BQ.1.1., according to data included in the EUA Fact Sheet for Healthcare Providers (PDF, 763 KB).  

• November 30, 2022: MCMi email - FDA authorizes a COVID-19 and flu point-of-care test | FDA & NIST advanced manufacturing collaboration

• November 28, 2022: FDA approved a new indication (PDF, 244 KB) for Udenyca (pegfilgrastim-cbqv) to increase survival of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS) as could occur after a radiological or nuclear event. Udenyca is the fifth FDA-approved medical countermeasure and first biosimilar that is indicated to increase survival in patients exposed to myelosuppressive doses of radiation. For more information, see the product label (PDF, 460 KB). 

• November 28, 2022: NIH is soliciting proposals for (a) the development of medical countermeasures (MCMs) against radiation injury or, (b) biodosimetry approaches targeting radiation-specific biomarker identification and/or device development to predict acute and/or delayed damage to specific organs and tissues beyond dose assessment through a new BAA announcement. Proposals are due by 3:00 p.m. EST February 27, 2023. 

• November 23, 2022: New Just a Minute! video: What does the future hold for FDA’s efforts to address COVID? (YouTube)

• November 22, 2022: FDA granted an EUA amendment (PDF, 347 KB) to add dizziness to all of the Pfizer-BioNTech COVID‑19 Vaccine Fact Sheets and to update the Fact Sheet for Healthcare Providers Administering Vaccine for 6 months through 4 Years of Age Dilute Before Use (PDF, 2.5 MB) to include new information on effectiveness of a 3-dose primary series in study participants 6 months through 4 years of age.

• November 22, 2022: FDA issued an EUA (PDF, 302 KB) for the Lucira COVID-19 and Flu Test for use in a point-of-care (POC) setting, following collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP).

• November 22, 2022: MCMi email - Advanced manufacturing updates | Fast facts for health care providers: bivalent COVID-19 vaccines

• November 21, 2022: The OCET Advanced Manufacturing Program aims to help FDA develop regulatory science tools and metrics, and facilitate industry adoption of these emerging technologies—especially to improve public health emergency response and supply chain resilience. Today, the Office of Counterterrorism and Emerging Threats (OCET), in the Office of the Chief Scientist, published a new website section with additional information about its advanced manufacturing program, including new pages about the I-TEAM Hub collaboration with HHS/ASPR, a smart design and manufacturing pilot program, and a partnership with the National Institute of Standards and Technology (NIST) to develop and benchmark methods to predict thermal stability of monoclonal antibodies. The section also includes new pages about advanced manufacturing research and projects, and public-private partnerships. The existing Advanced Manufacturing page will continue to include advanced manufacturing news, events, and funding opportunities from across FDA.

• November 17, 2022: New Just a Minute! video - Are the new bivalent COVID-19 vaccines safe? (YouTube)
• November 16, 2022: New fact sheet - Fast Facts for Health Care Providers: Data Points on the Bivalent COVID-19 Vaccination (PDF, 203 KB - ARCHIVED)
• November 16, 2022: MCMi email - New funding opportunities | COVID-19 and monkeypox response updates | Modeling & simulation at FDA 
• November 16, 2022: FDA published a new report, Successes and Opportunities in Modeling & Simulation for FDA. Computational modeling and simulation are powerful tools that complement traditional methods for gathering evidence about products regulated by FDA. FDA scientists routinely review results from M&S studies submitted by industry and use M&S approaches for scientific research and regulatory decision-making. This report presents a selection of modeling and simulation case studies from across FDA, illustrating how these technologies are playing an important role in helping FDA protect and promote public health.
• November 15, 2022: FDA issued an EUA (PDF, 254 KB) to Roche Molecular Systems, Inc. for the cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (EUA220459) for the qualitative detection of DNA from monkeypox virus in human lesion swab specimens from individuals suspected of monkeypox virus infection by their health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests. Also see: Monkeypox Emergency Use Authorizations for Medical Devices
• November 15, 2022: FDA posted an updated Pfizer-BioNTech COVID-19 Vaccine Presentations Wall Chart (PDF, 596 KB)
• November 15, 2022: FDA collaborated with MITRE to update the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, a resource to help health care delivery organizations prepare for cybersecurity incidents. The playbook focuses on preparedness and response for medical device cybersecurity issues that impact the functionality of a medical device.
• November 9, 2022: Funding opportunity - Innovation Award: COVID-19 and Health Equity - FDA's Office of Minority Health and Health Equity (OMHHE) has posted a funding opportunity for to COVID-19 research that will strengthen and advance research in minority health and healthy equity, increase understanding of health disparities, and provide future direction for research that will contribute to regulatory decision making. OMHHE is interested in research proposals that will contribute to advancing understanding of COVID and long COVID or post-COVID conditions for racial and ethnic minorities or contribute to informing the continued evaluation of the safety and efficacy of FDA approved products (therapeutics, diagnostics, and vaccines) for the treatment, prevention, or diagnosis of COVID-19. These research proposals should support evaluation of outcomes by demographic data including, but not limited to, ethnicity, race, age, disability and geography. Letters of intent are due by December 6, 2022, and applications are due by January 16, 2023.
• November 9, 2022: MCMi email - Why should I get the updated COVID-19 vaccine now? + COVID-19 therapeutics updates from FDA
• November 8, 2022: New Just a Minute! video: Why should I get my child an updated COVID-19 vaccine? (YouTube)
• November 8, 2022: FDA authorized (PDF, 256 KB) Kineret (anakinra) for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). For more information, see the fact sheets for health care providers (PDF, 626 KB) and patients and caregivers (PDF, 413 KB).
• November 4, 2022: FDA Updates on Bebtelovimab - FDA updated the Health Care Provider Fact Sheet (PDF, 763 KB) for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Prescribers should monitor CDC regional variant frequency data and refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants in your area, particularly Omicron subvariants BQ.1 and BQ.1.1. Read more
• November 4, 2022: FDA granted an extension (PDF, 177 KB) of the shelf-life of the authorized Moderna COVID-19 Vaccine. FDA is extending the expiration date of certain lots of the Moderna COVID-19 Vaccine, as listed in the table here, from 9 months to 12 months when stored at recommended long-term storage conditions of -50 °C to -15 °C. This duration may include up to 30 days of storage at 2 °C to 8 °C and up to 24 hours of storage at room temperature (25 °C).
• November 3, 2022: New Just a Minute! video: Why should I get the updated COVID-19 vaccine now? (YouTube)
• November 2, 2022: MCMi email - Public health emergency response updates from FDA, including COVID-19 and monkeypox
• November 1, 2022: FDA revised the EUAs of all COVID-19 antigen tests to revise the authorized uses and require updates to product labeling regarding repeat, or serial, testing. This action is in response to available data about the performance of COVID-19 antigen tests showing that repeat testing after a negative COVID-19 antigen test result increases the chance of an accurate result in people with and without symptoms and could help prevent people from unknowingly spreading the SARS-CoV-2 virus to others.  
• October 31, 2022: Monkeypox response: FDA launched a new web-based application for single-patient emergency use IND requests for Tembexa, a therapeutic option for patients with human monkeypox disease who meet specific eligibility criteria. Additional information about Tembexa is available at FDA Monkeypox Response: Therapeutics.
• October 31, 2022: FDA announced a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. FDA is implementing this pilot program to facilitate CMC readiness for selected Center for Biologics Evaluation and Research (CBER)- and Center for Drug Evaluation and Research (CDER)-regulated products with accelerated clinical development timelines. For sponsors participating in the pilot, FDA will provide product-specific CMC advice during product development, to include two additional CMC-focused Type B meetings, as well as a limited number of additional CMC-focused discussions, based on readiness and defined CMC milestones.
• October 28, 2022: FDA and HHS/ASPR announced the authorization of an additional extension to the shelf life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use. 
• October 27, 2022: HHS/ASPR published the Public Health and Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan 2022. The plan includes an updated list of PHEMCE high-priority threats. 
• October 26, 2022: MCMi email - COVID-19 vaccine and therapeutics updates | Monkeypox LDT list
• October 20, 2022: FDA updated its Monkeypox and Medical Devices page to provide lists of certain laboratories that have notified the FDA of their laboratory developed monkeypox diagnostic test, modification to an FDA-cleared or EUA-authorized monkeypox diagnostic test, or laboratory developed monkeypox serology test, as described in Sections IV.A.2, IV.A.3, and IV.C, respectively, of the Policy for Monkeypox Tests to Address the Public Health Emergency.  While FDA has not reviewed the laboratory’s validation of the listed tests and has not issued EUAs for these tests, we are providing this information to promote transparency. 
• October 20, 2022: Frequently Asked Questions on the Emergency Use Authorization for Evusheld (tixagevimab co-packaged with cilgavimab) for Pre-exposure Prophylaxis (PrEP) of COVID-19 (PDF, 262 KB) have been updated to include answers to questions including: Is Evusheld still an appropriate option for eligible patients? (in light of SARS-CoV-2 circulating variants), and Are people who have received Evusheld eligible to receive COVID-19 treatments if they develop COVID-19?
• October 19, 2022: FDA authorized use (PDF, 892 KB) of Novavax COVID‑19 Vaccine, Adjuvanted as a first booster dose to the following individuals at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine, and revised the fact sheets to reflect these changes:
  • Individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and
  • Individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. 
• October 19, 2022: MCMi email - Public health emergency response news from FDA | Regulatory science & funding updates
• October 18, 2022: FDA issued an EUA (PDF, 328 KB) for the first over-the-counter saliva-based molecular test to Aptitude Medical Inc. for their Metrix COVID-19 Test, a single-use molecular diagnostic test for the detection of SARS-CoV-2.

• October 18, 2022: HHS news release - HHS Announces Actions to Counter Biological Threats, Enhance Pandemic Preparedness, and Achieve Health Security - HHS announced actions the department will take following National Security Memorandum 15, signed by President Biden, directing implementation of the 2022 National Biodefense Strategy and Implementation Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (PDF, 547 KB). The strategy and implementation plan detail a coordinated approach to address the challenges from naturally occurring, deliberate, and accidental biological threats. These threats are among the most serious threats facing the U.S. and the international community. The 2022 strategy builds on the 2018 National Biodefense Strategy, incorporating lessons learned during the COVID-19 pandemic, and laying out a comprehensive implementation plan with bold, concrete actions to transform our health security.

• October 18, 2022: FDA granted an extension (PDF, 203 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps). Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown here, as long as approved storage conditions noted in the updated fact sheet for health care providers (PDF, 2.6 MB) have been maintained.
• October 13, 2022: FDA and other agencies are collaborating with NASA on a research project to extend the life of 3D tissue chips, which will allow longer-term studies to help scientists better understand disease models, and inform drug development and clinical trial design. NASA announced the teams of researchers working to extend the tissue chip longevity to study a wide variety of biological changes including neurotoxic stressors, radiation exposure, and acute and chronic exposures to drugs.
• October 13, 2022: FDA's Center for Drug Evaluation and Research (CDER) has issued a discussion paper, Distributed Manufacturing and Point-of-Care Manufacturing of Drugs. This discussion paper presents areas associated with distributed manufacturing (DM) and point-of-care (POC) manufacturing that FDA has identified for consideration as FDA evaluates our existing risk-based regulatory framework as it applies to these technologies. The discussion paper does not constitute guidance; instead, its purpose is to gather feedback from the public to inform future policy development. The discussion paper considers relevant background, including terminology, to the FDA’s regulation of DM and POC, identifies challenges presented by DM and POC, and poses key questions to facilitate public comment. FDA is seeking input on each of these topics and on 20 questions posed in the discussion paper. FDA encourages stakeholders to provide comments under docket number FDA-2022-N-2316, by December 13, 2022. Also see: CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative and FDA Seeks Feedback on Distributed and Point-of-Care Drug Manufacturing
• October 12, 2022: Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA - Jiangsu Well Biotech Co., Ltd. is recalling COVID-19 Ag Rapid Test Devices because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. The company has not provided the FDA with adequate validation data to show that the test’s performance is accurate. This means there is a risk of potential false negative, false positive, or misinterpretation of results.
• October 12, 2022: MCMi email - FDA authorizes bivalent COVID-19 vaccine boosters in younger age groups | First commercial test kit for detection of monkeypox
• October 12, 2022: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups - FDA amended the EUAs of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age. 
• October 7, 2022: First commercial test kit authorized for detection of monkeypox - FDA issued an EUA (PDF, 250 KB) to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The Alinity m MPXV test is the first commercial test kit to be authorized for detection of monkeypox. The Alinity m MPXV test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests. 
• October 7, 2022: The White House released the National Strategy for Advanced Manufacturing (PDF, 1 MB). Goals of the strategy are to 1) Develop and implement advanced manufacturing technologies, 2) Grow the advanced manufacturing workforce, and 3) Build resilience into manufacturing supply chains and ecosystems. Learn more about advanced manufacturing at FDA
• October 5, 2022: MCMi email - Latest updates about Evusheld for PrEP for COVID-19 
• October 4, 2022: FDA Launches Biosimilar Regulatory Science Program - As outlined in the biosimilar user fee act (BsUFA) reauthorization commitment letter (PDF, 205 KB) for fiscal years 2023-2027 (BsUFA III), FDA will pilot a regulatory science program to further advance biosimilar and interchangeable biological product development. The program will focus on enhancing regulatory decision-making and facilitating science-based recommendations in areas foundational to biosimilar and interchangeable product development.

• October 3, 2022: Latest information and updates about Evusheld for PrEP for COVID-19 - FDA added important information to the authorized Fact Sheets for Evusheld (tixagevimab co-packaged with cilgavimab) to inform health care providers and individuals receiving Evusheld of the increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that are not neutralized by Evusheld. Detailed neutralization data can be found in the revised authorized Fact Sheet for Healthcare Providers (PDF, 697 KB). Health care professionals should inform patients of this risk and advise patients who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and promptly seek medical attention, including starting treatment for COVID-19, as appropriate if they test positive.   

• September 29, 2022: Why is FDA allowing intradermal delivery of the monkeypox vaccine? (new Just a Minute! video with CBER Director Dr. Peter Marks)

• September 28, 2022: MCMi email - FDA updates COVID-19 test policy | New printable COVID-19 vaccine wall charts including bivalent boosters

• September 27, 2022: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types - FDA updated its COVID-19 test policy to ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways. The updated policy describes the FDA’s intent to review only a small subset of new emergency use authorization (EUA) requests for diagnostic tests and encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance pre-market review pathways. Also see: FAQs on Testing for SARS-CoV-2

• September 21, 2022: Monkeypox response: New and recently updated Just a Minute! videos: 

  • When it comes to vaccines, what does intradermal mean? (YouTube) (new)

  • Is there a vaccine to prevent monkeypox? How does it work? (YouTube) (updated)

• September 21, 2022: Health care providers: Printable wall charts updated to include the COVID-19 vaccine bivalent booster presentations are now available:

  • Available Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Presentations (PDF, 497 KB)

  • Currently Available Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent Presentations (PDF, 512 KB)

• September 21, 2022: The Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers (PDF) for use in individuals 12 years of age and older, including bivalent booster information, is now also available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese.

• September 21, 2022: MCMi email - New webinar series for monkeypox test developers starts today | Save the date for BAA Industry Day + more news & events

• September 20, 2022: FDA announced a collaboration with NIH for funding opportunities to support small businesses in developing medical device development tools (MDDTs).

• September 15, 2022: Fast Facts on the Intradermal JYNNEOS Monkeypox Vaccine (PDF, 194 KB) is now available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese

• September 14, 2022: The U.S. Department of Health and Human Services (HHS) announced actions the department will take following the Executive Order signed September 12, 2022 by President Biden launching a National Biotechnology and Biomanufacturing Initiative (NBBI). In its implementation of the Executive Order, HHS intends to leverage biotechnology and biomanufacturing in order to achieve medical breakthroughs, reduce the overall burden of disease, and improve health outcomes. HHS will lead the U.S. government in strategically advancing biosafety and biosecurity innovation as part of a growing bioeconomy, to ensure biotechnology research and development and biomanufacturing infrastructure break new ground while reducing risk. This includes supporting development of the Advanced Manufacturing Innovation Hub in the FDA’s Office of Counterterrorism and Emerging Threats (OCET) to facilitate creation of regulatory science benchmarks and strategies for platform technologies and to drive collaborations that affect multiple product areas (e.g., smart manufacturing, closed loop process controls).

• September 14, 2022: MCMi email - FDA takes significant action to help expand access to monkeypox testing | COVID-19 response updates from FDA

• September 12, 2022: Monkeypox response: FDA released additional information in publicly posted reviews supporting approval of the new drug application for tecovirimat to describe specific changes in the VP37 proteins of orthopoxviruses (e.g., vaccinia virus and monkeypox virus) that are associated with tecovirimat drug resistance. FDA is releasing this information to aid the scientific community’s genomic sequencing efforts to support national surveillance of the current monkeypox virus outbreak in the U.S. We believe this additional information will further facilitate the ability to monitor for the development and spread of tecovirimat-resistant virus and therefore is important in promoting public health. Additional information on FDA’s response to the public health emergency, including summary information on tecovirimat drug resistance, is available at: FDA Monkeypox Response. Also see from CDC: Guidance for Tecovirimat Use Under Expanded Access Investigational New Drug Protocol during 2022 U.S. Monkeypox Outbreak (September 15, 2022)

• September 12, 2022: FDA reissued the August 19, 2022, letter of authorization (PDF, 863 KB) for Novavax COVID-19 Vaccine, Adjuvanted to revise the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Novavax, Inc. to include myocarditis and pericarditis.  Because some cases of myocarditis or pericarditis following vaccine administration may not meet the definition of serious adverse events, this change will help ensure that cases of myocarditis and pericarditis are reported by Novavax, Inc. and vaccination providers to VAERS. The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (PDF, 1.3 MB) has also been revised to include information about this updated reporting requirement. 

• September 9, 2022: FAQs on Testing for Monkeypox - New page with answers to frequently asked questions relating to the development and performance of tests for monkeypox, primarily  intended for monkeypox test developers

• September 8, 2022: NIH seeks the next generation of COVID-19 diagnostics - The National Institutes of Health has issued two new funding opportunities for diagnostic test manufacturers to develop the next generation of COVID-19 tests, with a major focus on accessibility. The funding opportunities are part of the Rapid Acceleration of Diagnostics (RADx) Tech program, managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The new programs may award up to $300 million in funds from the American Rescue Plan Act of 2021 to support the accelerated development of tests and provide regulatory guidance during the COVID-19 pandemic and beyond. More from NIH: RADx^® Tech and ATP Programs

• September 7, 2022: Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing - FDA issued guidance that outlines the agency’s current thinking regarding enforcement policies, recommendations for EUA requests for monkeypox diagnostic tests, and the FDA’s plans to prioritize review of EUA requests. The agency is also providing voluntary templates that test developers may use when validating a test or when submitting an EUA request. In addition to the guidance, FDA issued the first EUA (PDF, 464 KB) for a monkeypox in vitro diagnostic. Also see:

  • Monkeypox and Medical Devices (new page)

  • Monkeypox Emergency Use Authorizations for Medical Devices (new page)

  • Emergency Use Authorization - Monkeypox In Vitro Diagnostics EUAs (new section)

  • HHS Secretary Becerra Issues 564 Declaration to Expand the Availability of Testing for Monkeypox (HHS press release)

• September 7, 2022: MCMi email - What is a bivalent vaccine? +more COVID-19 booster info, and September/October events

• September 7, 2022: The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative established the Independent Test Assessment Program (ITAP) to accelerate regulatory review and availability of high-quality, accurate, and reliable over-the-counter COVID-19 tests to the public. ITAP is accepting new proposals on a rolling basis to address the diagnostic needs of the monkeypox outbreak. ITAP support will help accelerate the validation, regulatory authorization, and commercialization of point-of-care (POC) and home monkeypox virus tests. Proposals for POC and home tests that can directly detect the monkeypox virus and kits for at-home monkeypox virus self-collection are being accepted as of September 7, 2022. NIBIB will consider applications only from test manufacturers with existing technologies for monkeypox virus that can quickly scale production and meet FDA's performance/quality standards. More information is available on the submission portal. 

• September 6, 2022: FDA Authorizes Shelf Life Extension for Certain Lots of Paxlovid - FDA and HHS/ASPR authorized an extension to the shelf life from 12 months to 18 months for certain lots of the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use). As a result of this extension, lots of Paxlovid with dates of expiry from July 2022 to May 2023 may be stored for an additional six months from the labeled date of expiry (see Table 1 here) when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.3 MB).

• September 6, 2022: FDA safety communication: Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices - Also see the related letter to health care providers 

• September 6, 2022: FDA published the 2022 Focus Areas of Regulatory Science (FARS) report, which outlines topics the agency has identified as needing continued targeted investment in regulatory science research to facilitate the development of innovative products, provide data and methods to inform regulatory decision-making and improve guidance to sponsors. Public health preparedness and response is a focus area, including medical countermeasures and preparedness for emerging infectious diseases. 

• September 2, 2022: FDA posted new Just a Minute! videos with CBER Director Dr. Peter Marks including, What is in the authorized updated (bivalent) COVID-19 boosters? and Why should I get one of the updated COVID-19 vaccine boosters?

• September 2, 2022: In August, FDA approved a New Drug Application (NDA) for the use of Midazolam Injection, 10 mg/0.7 mL, autoinjector, for the treatment of status epilepticus in adults. The Department of Defense (DoD) developed the product with Rafa Laboratories, Ltd. According to JPEO-CBRND (the U.S. Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense), the autoinjector "improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA) diazepam autoinjector."  For more information, see the NDA approval letter (PDF, 302 KB) and product label (PDF, 913 KB).

• September 1, 2022: FDA posted new Just a Minute! videos with CBER Director Dr. Peter Marks including, What is a bivalent vaccine? and What data support the use of the updated COVID-19 boosters?

• September 1, 2022: FDA Voices: Using A Whole-Of-Governments Approach to Combating Illicit Health Products, including fraudulent COVID-19 products

• August 31, 2022: MCMi email - FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose | Media call today at 10:45 a.m. ET

• August 31, 2022: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose - FDA amended the EUAs of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines, which we will also refer to as “updated boosters,” contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older. Also see: COVID-19 Bivalent Vaccine Boosters (new page)
  
  With this authorization, FDA has also revised the EUAs of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older, respectively. These monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older as described in the letters of authorization.

• August 29, 2022: Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Monkeypox Virus and HCT/P Donation

• August 26, 2022: FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply - FDA announced the removal of N95 respirators from the agency’s medical device shortage list, signaling that demand or projected demand for this type of face protection device commonly used in health care settings no longer exceeds the supply. This action is the result of increased domestic manufacturing of N95 respirators, as well as updates to the FDA’s supply chain assessment based on engagement with industry and federal stakeholders, and the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health’s (NIOSH) approval of new disposable N95s and reusable respirators. Also see: Supplies of Medical Devices for COVID-19: Frequently Asked Questions

• August 26, 2022: FDA updated Frequently Asked Questions on the Emergency Use Authorization of Bebtelovimab for the Treatment of COVID-19 (PDF, 953 KB) to revise information about distribution of this product. 

• August 26, 2022: FDA updated the Fact Sheet for Health Care Providers (PDF, 1.5 MB) for Lagevrio (molnupiravir) to link to the most current information for health care providers related to medical conditions and factors associated with increased risk for progression to severe COVID-19.

• August 26, 2022: FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this time (a listing of additional resources is provided at the end of the checklist). Please see the updated Paxlovid Patient Eligibility Screening Checklist and Drug Interaction Tool (PDF, 995 KB) for more information. 

• August 26, 2022: The material threat medical countermeasure priority review voucher (MCM PRV) web page has been updated to include a table listing redeemed MCM PRVs.

• August 25, 2022: FDA's Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) published its Fiscal Year 2021 Report on the State of Pharmaceutical Quality (PDF, 1.1 MB) to provide information on the quality of the U.S. drug supply and OPQ’s quality surveillance during COVID-19.

• August 24, 2022: MCMi email - Check your COVID-19 test expiration dates | Monkeypox response updates from FDA

• August 22, 2022: Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to Monkeypox Virus

• August 19, 2022: Sentinel Initiative report: Differences in COVID-19 Testing, Positivity, Hospitalization, and Mortality by Race and Ethnicity in the Sentinel Distributed Database: A Descriptive Analysis

• August 19, 2022: FDA authorized the emergency use (PDF, 913 KB) of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age. This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA. The agency previously authorized the vaccine for individuals 18 years and older. Also see the updated fact sheets for recipients/caregivers (PDF, 703 KB) and health care providers (PDF, 1.2 MB).

• August 18, 2022: Monkeypox response: FDA Fast Facts: Jynneos (PDF, 222 KB) is now also available in Chinese (Simplified) (PDF, 698 KB), Korean (PDF, 708 KB), Spanish (PDF, 679 KB), Tagalog (PDF, 669 KB), and Vietnamese (PDF, 769 KB).

• August 18, 2022: Intradermal Jynneos Monkeypox Vaccine Fast Facts (PDF, 200 KB) 

• August 18, 2022: Report: FDA's Work to Combat the COVID-19 Pandemic (PDF, 4.9 MB) - Outlines much of the broad range of work the FDA is undertaking to combat the COVID-19 pandemic and prepare for future emergencies.

• August 17, 2022: National Center for Toxicological Research (NCTR) Research Highlight: Monitoring SARS-CoV-2 and Its Variants in Arkansas Wastewater

• August 17, 2022: MCMi email - COVID-19 and monkeypox response updates from FDA | Monkeypox vaccine fact sheet in multiple languages

• August 16, 2022: Monkeypox response: FDA granted an EUA amendment (PDF, 133 KB) for changes to preparation and storage instructions on the Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization of Jynneos (Smallpox and Monkeypox Vaccine, Live, Non-Replicating) for Prevention of Monkeypox Disease in Individuals Determined to be at High Risk for Monkeypox Infection (PDF, 343 KB). Once thawed, the vaccine may be kept at +2°C to +8°C (+36°F to +46°F) for 8 weeks. To get the most 0.1 mL doses for intradermal use from each vial make sure to use low dead volume needles and syringes.

• August 16, 2022: Monkeypox response: The Jynneos vaccine EUA fact sheet for recipients and caregivers is now available in five additional languages. 

• August 12, 2022: Monkeypox response: FDA Fast Facts: TPOXX (PDF, 655 KB) is now also available in Chinese (Simplified) (PDF, 649 KB), Korean (PDF, 659 KB), Spanish (PDF, 634 KB), Tagalog (PDF, 631 KB), and Vietnamese (PDF, 721 KB).

• August 12, 2022: Information for Blood Establishments Regarding the Monkeypox Virus and Blood Donation

• August 11, 2022: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication - FDA is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, to reduce the risk an infection may be missed (false negative result) and to help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms.

• August 10, 2022: MCMi email - Public health emergency response updates from FDA: COVID-19 and monkeypox updates

• August 9, 2022: Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

• August 9, 2022: White House Fact Sheet: Biden Administration Announces Key Actions and Implementation Plan to Increase Vaccine Supply 

• August 9, 2022: HHS press release - HHS Secretary Becerra issues 564 determination, paving way for emergency use authorization of monkeypox vaccines - Also see: Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency and Declaration that Circumstances Exist Justifying and Authorization Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)

• August 8, 2022: FDA approved a New Drug Application (NDA) for the use of Midazolam Injection, 10 mg/0.7 mL, autoinjector, for the treatment of status epilepticus in adults. The Department of Defense (DoD) developed the product with Rafa Laboratories, Ltd. According to JPEO-CBRND (the U.S. Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense), the autoinjector "improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA) diazepam autoinjector."  For more information, see the NDA approval letter (PDF, 302 KB) and product label (PDF, 913 KB).

• August 5, 2022: New web page: Rumor Control - The growing spread of rumors, misinformation and disinformation about science, medicine, and the FDA, is putting patients and consumers at risk. We’re here to provide the facts.

• August 2022: Funding Opportunity Announcement: Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments - FDA seeks to continue a robust, collaborative, and educational program using problem-based learning techniques designed to bring researchers and regulators together to educate each other on the challenges related to these issues and to identify solutions that are acceptable from both scientific and regulatory perspectives. This program consists of the continued development and implementation of a certified, academic training course for instruction in Good Laboratory Practices (GLP) in a Biosafety Level (BSL) 4 High Containment Environment. Applications are due by 11:59 p.m. ET, October 3, 2022. 

• July 29, 2022: FDA Provides Update on Agency Response to Monkeypox Outbreak - Also see: FDA Monkeypox Response and Key Facts About Monkeypox Vaccine

• July 29, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months. 

• July 27, 2022: Increasing Agility, Digital Integration in FDA-Regulated Manufacturers - Digital manufacturing institute MxD conducted a study to help FDA understand how and why companies are making decisions to implement digital technology in their operations.

• July 26, 2022: Paxlovid shelf-life extension - When FDA first issued the EUA authorizing Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), it established a 12-month product shelf-life. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. FDA has authorized extended expiration dates for these lots to reflect the 12-month product shelf-life (see Table 1: Extended Expiry Dating for Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use) Authorized under EUA 105), when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for EUA 105 for Paxlovid.

• July 22, 2022: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to include information about genotyping tests authorized for the identification and differentiation of specific SARS-CoV-2 mutations, lineages, or variants.

• July 20, 2022: New Q&A with FDA Podcast Series: Conversation on Paxlovid and COVID-19

• July 20, 2022: MCMi email - COVID-19 response updates from FDA | Monkeypox testing safety communication 

• July 19, 2022: FDA updated the device shortage list and the device discontinuance list on the web page Medical Device Shortages During the COVID-19 Public Health Emergency. In addition, the FDA is providing information about devices that have been removed from the device shortage list at this time. FDA also updated the Supplies of Medical Devices for COVID-19: Frequently Asked Questions web page to provide information about how the FDA determines to remove product codes from the device shortage list and what the FDA is doing to help medical device manufacturers with the global shortage of semiconductor chips.

• July 15, 2022: For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication

• July 15, 2022: HHS orders additional vaccine, increases testing capacity to respond to monkeypox outbreak (HHS press release) - The FDA recently announced that it has completed its inspection of the Bavarian Nordic manufacturing facility in Denmark. Observations from inspections inform FDA’s evaluation of other quality information submitted by sponsors, which are critical to helping ensure vaccines’ safety and effectiveness. Doses from the facility can potentially be approved by the end of July, which would mean that approximately 780,000 additional doses would be added to the government’s available supply.

• July 14, 2022: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to include information about genotyping tests authorized for the identification and differentiation of specific SARS-CoV-2 mutations, lineages, or variants.

• July 13, 2022: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted - FDA issued an EUA (PDF, 899 KB) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. Also see: Novavax COVID-19 Vaccine

• July 13, 2022: MCMi email - FDA authorizes pharmacists to prescribe Paxlovid | Advanced manufacturing job openings

• July 12, 2022: Apply to join the Office of Counterterrorism and Emerging Threats (OCET) Advanced Manufacturing team, to help advance public health emergency preparedness and patient access to medical products through development of tools and approaches to enhance the evaluation of advanced manufacturing technologies and facilitate their adoption by regulated industries. Apply by August 1, 2022. For more information see the Staff Fellow job announcements: 

  • OCET Research Engineer (PDF, 159 KB) (General Engineer)

  • OCET Research Scientist (PDF, 146 KB) (General Health and Medical Sciences)

• July 8, 2022: FDA approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 15 years of age. The approval follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by FDA. The Pfizer-BioNTech COVID-19 Vaccine has been, and will continue to be, authorized for emergency use in this age group since May 2021. COMIRNATY (COVID-19 Vaccine, mRNA) has been approved for use in individuals 16 years of age and older since August 2021. 

• July 6, 2022: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations - The FDA revised the Emergency Use Authorization (EUA) (PDF, 783 KB) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. Also see: Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment of COVID-19 (PDF, 995 KB)

• July 6, 2022: MCMi email - COVID-19 vaccine and therapeutic updates | FDA seeking consumer representatives for advisory committees

• July 1, 2022: FDA is requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. For advisory committee vacancies listed in this notice, and those that may occur through December 31, 2023. Nomination materials are due by August 15, 2022. 

• June 30, 2022: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses and new web page: Update: COVID-19 Vaccine Booster Composition 

• June 29, 2022: FDA authorizes revisions to Evusheld dosing to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection

• June 29, 2022: MCMi email - Updates from FDA on COVID-19 medical countermeasures, monkeypox testing, advanced manufacturing, and more

• June 28, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. FDA granted this extension following a thorough review of data submitted by AstraZeneca. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 712 KB) and the EUA Letter of Authorization (PDF, 293 KB) for Evusheld. As required by the EUA, of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab), must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

• June 28, 2022: An FDA Self-Audit of Continuous Manufacturing for Drug Products (podcast and newsletter) - Continuous manufacturing (CM) technology has the potential to improve product quality and reliability, lower manufacturing costs, reduce waste, decrease inventory, and increase manufacturing flexibility and agility in response to product demand. Alternatively, is it possible that CM can also increase time to regulatory approval and market entry, hinder submission of post-approval changes, and raise inspectional scrutiny? CDER’s Office of Pharmaceutical Quality (OPQ) set out to find answers by conducting a self-audit of approved U.S. regulatory submissions that employ CM vs. traditional batch processes, and analyzing regulatory outcomes during the product lifecycle and at approval.

• June 27, 2022: FDA's Center for Drug Evaluation and Research published its 2021 Office of New Drugs Annual Report (PDF, 8.5 MB), including efforts during the second year of the COVID-19 pandemic, specifically related to trial designs for COVID-19 therapies, collaboration with drug sponsors, and issuance of guidances addressing the impact of emergent variants on drug development.

• June 27, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together, or REGEN-COV. Due to the high frequency of the omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.7 MB) and the EUA Letter of Authorization (PDF, 1 MB).

• June 22, 2022: MCMi email - FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age

• June 17, 2022: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age - For the Moderna COVID-19 Vaccine, the FDA amended (PDF, 1 MB) the Emergency Use Authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older. For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA (PDF, 1.3 MB) to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. A recording of the virtual press conference is available (32 minutes). 

• June 16, 2022: Testimony by FDA Commissioner Dr. Robert Califf: An Update on the Ongoing Federal Response to COVID-19: Current Status and Future Planning

• June 15, 2022: MCMi email - First COVID-19 test to identify specific SARS-CoV-2 lineages authorized

• June 10, 2022: FDA issued an EUA (PDF, 261 KB) for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system.  This is the first COVID-19 test to identify specific SARS-CoV-2 lineages. Read more: Individual EUAs for Genotyping Tests for SARS-CoV-2 

• June 8, 2022: MCMi email - COVID-19 updates from FDA | Collaborating to enhance testing capacity during public health emergencies

• June 3, 2022: FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19.  Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet (PDF, 619 KB) or checklist at this time (a listing of additional resources is provided at the end of the checklist). Please see the updated Prescriber Patient Eligibility Screening Checklist (PDF, 279 KB) for more information.

• June 1, 2022: In May 2022, FDA, the Centers for Disease Control and Prevention (CDC), and several stakeholders signed a Memorandum of Understanding (MOU) to collaborate on enhancing laboratory testing surge capacity outside of CDC and public health laboratories before and during public health emergencies. Partnerships and engagement between the public and private sector are crucial to supporting a significant increase in demand for diagnostic testing during a public health emergency and to respond to emerging public health threats before reaching the level of a pandemic.

• June 1, 2022: MCMi email - June event updates: vaccine advisory committees, register now for July course on clinical trials involving high-consequence pathogens

• May 26, 2022: FDA has posted information about Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings in June

• May 25, 2022: MCMi email - Updated vaccine advisory committee dates | Know your treatment options for COVID-19

• May 23, 2022: Essential Medicines Report Now Available - The nation’s first Essential Medicines Supply Chain and Manufacturing Resilience Assessment by the U.S. government was released by the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR). The assessment addresses pharmaceutical supply chain constraints identified in the Biden-Harris Administration’s 100-day supply chain review report, specifically those constraints affecting critical medicines on the FDA’s essential medicines list. Download the full report here.

• May 23, 2022: FDA revised the dates of two upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings due to new data from sponsors and expected submissions of EUA requests. VRBPAC will discuss Moderna’s EUA request for 6 years through 17 years of age on June 14, 2022, and will discuss the Moderna EUA request for 6 months through 5 years of age and Pfizer-BioNTech EUA request for 6 months through 4 years of age on June 15, 2022. 

• May 20, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use. FDA granted this extension following a thorough review of data submitted by Eli Lilly. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 here). This extension applies to all unopened vials of bebtelovimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 433 KB) and the EUA Letter of Authorization (PDF, 111 KB) for bebtelovimab. As required by the EUA, unopened vials of bebtelovimab injection, 175 mg/2 mL, must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

• May 18, 2022: FDA approved an intravenous (IV) formulation (PDF, 565 KB) of TPOXX (tecovirimat) to treat smallpox. The oral formulation of the drug was originally approved in 2018. The IV formulation is an option for those who are unable to swallow the oral capsule. Also see: Smallpox Preparedness and Response Updates from FDA

• May 19, 2022: FDA urges drug manufacturers to develop risk management plans to promote a stronger, resilient drug supply chain - Also see the draft guidance: Risk Management Plans to Mitigate the Potential for Drug Shortages

• May 19, 2022: FDA updated its safety communications and frequently asked questions about the Philips Respironics ventilator, BiPAP machine, and CPAP machine recalls on FDA.gov to provide the latest information about medical device reports associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam.

• May 18, 2022: MCMi email - FDA expands eligibility for Pfizer-BioNTech COVID-19 Vaccine booster dose to children 5 through 11 years

• May 17, 2022: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years - FDA reissued (PDF, 483 KB) the EUA for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine. 

• May 16, 2022: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV

• May 16, 2022: Woodside Acquisitions Inc Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA

• May 12, 2022: Statement Regarding Shelf-Life Extension of Sotrovimab (from HHS/ASPR and FDA) – The shelf-life of sotrovimab continues to be evaluated. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. However, it is recommended that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the United States. All sotrovimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates. This recommendation applies to all unopened vials of sotrovimab that have been held in accordance with storage conditions (refrigerated temperature at 2°C to 8°C (36°F to 46°F)) detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.38 MB) and the Letter of Authorization (PDF, 488 KB). 

• May 10, 2022: MCMi email - COVID-19 response updates from FDA: vaccines, tests, treatments, regulatory science & more

• May 9, 2022: Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination 

• May 5, 2022: Wastewater surveillance from SARS-CoV-2 variants (update) - Through the American Rescue Plan Act of 2021, Congress provided temporary funding for FDA to develop the capacity to sequence SARS-CoV-2 RNA from wastewater samples and to conduct a sampling and sequencing project through 2022. To facilitate sharing of information about progress on this sequencing effort, FDA published a public dashboard that graphically presents information from the project. Studies have shown that SARS-CoV-2 (COVID-19) variants of concern from wastewater can be identified 1-2 weeks prior to being detected in clinical samples from the same area, making wastewater surveillance useful for detecting and monitoring SARS-CoV-2 in the population. Raw sequence data plus a standard suite of metadata is available for download. 

• May 5, 2022: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals - FDA has limited the authorized use (PDF, 299 KB) of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

• May 4, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab. Due to the high frequency of the omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 773 KB) and the Letter of Authorization (PDF, 488 KB). 

• May 4, 2022: FDA posted a new CDER Conversation: FDA Updates on Paxlovid for Health Care Providers, including a new eligibility screening checklist tool (PDF, 247 KB). Paxlovid is the preferred therapy for the management of non-hospitalized adults with COVID-19, according to the National Institutes of Health COVID-19 Treatment Guidelines.

• May 4, 2022: MCMi email - COVID-19 at-home test updates: expiration date extensions, watch out for counterfeit tests

• April 29, 2022: COVID-19 Vaccine Boosters: Getting the Facts Straight - The FDA Office of Minority Health and Health Equity (OMHHE) has released a new episode of the Health Equity Forum podcast. In the latest episode, RADM Richardae Araojo, FDA's Associate Commissioner for Minority Health and Director of OMHHE, is joined by Dr. Robert Califf, the FDA Commissioner. During this episode, they discuss COVID-19 vaccines and boosters misinformation. You can find the episode on our website (including a transcript) and on Apple Podcasts, Google Podcasts, Spotify, and Pandora. 

• April 29, 2022: FDA recognizes that consumers and farmers may have questions over recent reports of Highly Pathogenic Avian Influenza (HPAI) outbreaks in the United States. FDA published a short questions and answers web page regarding the safety of eggs during HPAI outbreaks.

• April 29, 2022: FDA is aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the United States. These counterfeit tests should not be used or distributed.

• April 29, 2022: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines - FDA announced plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of EUA requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.

• April 28, 2022: FDA updated the page, At-Home OTC COVID-19 Diagnostic Tests, to include expiration date information to help consumers find the current expiration date for any FDA authorized OTC COVID-19 diagnostic test. 

• April 27, 2022: MCMi email - FDA approves first COVID-19 treatment for young children 

• April 26, 2022: On April 26, 2022, FDA granted an extension (PDF, 179 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps) from 9 months to 12 months when stored between -90°C to -60°C.

• April 25, 2022: FDA Approves First COVID-19 Treatment for Young Children - FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. 
  This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the EUA for Veklury that previously covered this pediatric population. Before now, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with COVID-19. 

• April 14, 2022: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples - FDA issued an EUA (PDF, 448 KB) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage. The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes. Also see the new web page: In Vitro Diagnostics EUAs - Other Diagnostic Tests for SARS-CoV-2

• April 13, 2022: Statement Regarding Shelf-Life Extension of Bamlanivimab and Etesevimab (from HHS/ASPR and FDA) - Evaluation of future extension of shelf-life for bamlanivimab and etesevimab is ongoing and an update regarding shelf-life extension for bamlanivimab and/or etesevimab is planned for early May 2022. Therefore, in the interim, all bamlanivimab and etesevimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates. More info: Expiration Dating Extension: COVID-19 Therapeutics

• April 13, 2022: FDA granted an extension (PDF, 374 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine for the two presentations of the Tris/Sucrose formulation (supplied in multiple dose vials with orange caps and labels with an orange border and in multiple dose vials with gray caps and labels with a gray border). The frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF) for up to 12 months from the date of manufacture. 

• April 13, 2022: MCMi email - FDA authorizes more OTC at-home COVID-19 tests | Shelf life extension for a COVID-19 vaccine

• April 7, 2022: FDA authorized an extension (PDF,  136 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. Learn more: Expiration Dating Extensions - COVID-19 Vaccines

• April 6, 2022: MCMi email - EUA updates and FAQs | Watch live today: VRBPAC meeting

• April 5, 2022: New FAQs: What happens to EUAs when a public health emergency ends?

• April 5, 2022: Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the omicron BA.2 sub-variant.  CDC Nowcast data from April 5, 2022,  estimates that the proportion of COVID-19 cases caused by the omicron BA.2 variant is above 50% in all HHS U.S. regions. Data included in the health care provider fact sheet (PDF, 1.4 MB) show the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant. Due to these data, sotrovimab is not authorized in any U.S. state or territory at this time.  Health care providers should use other approved or authorized products as they choose appropriate treatment options for patients.  FDA will continue to monitor BA.2 in all U.S. regions and will provide follow-up communication when appropriate. 

• March 30, 2022: The U.S. government has launched a new one-stop shop website, COVID.gov, to help all people in the United States gain even better access to lifesaving tools like vaccines, tests, treatments, and masks, as well as get the latest updates on COVID-19 in their area. Learn more: Fact Sheet: Biden Administration Launches COVID.gov, a New One-Stop Shop Website for Vaccines, Tests, Treatments, Masks, and the Latest COVID-⁠19 Information

• March 30, 2022: MCMi email - FDA authorizes second booster dose of two COVID-19 vaccines for ages 50+ and immunocompromised individuals

• March 29, 2022: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals - FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death. Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns. Also see: Media Call: Second COVID-19 Vaccine Booster Dose (12: 30 p.m. ET, March 29)

• March 28, 2022: FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs, including pandemic preparedness 

• March 25, 2022: FDA limits use of sotrovimab to treat COVID-19 in some U.S. regions due to the BA.2 omicron sub-variant - New data included in the health care provider fact sheet (PDF, 1.4 MB) shows that the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant. Based on CDC Nowcast data, the BA.2 sub-variant is eeestimated to account for more than 50% of cases in the states and territories in HHS Regions 1 and 2 as of March 19, 2022.

• March 23, 2022: MCMi email - COVID-19 test safety information | MCMi job alert: Regulatory counsel

• March 21, 2022: Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm 

• March 21, 2022: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters - FDA will hold a Vaccines and Related Biological Products Advisory Committee (VRBPAC) on April 6, 2022, to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants

• March 18, 2022: Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication - FDA issued a safety communication to alert people of the potential for harm if FDA-authorized at-home COVID-19 tests are not used according to the manufacturer’s test instructions. FDA is also reminding people to keep the tests out of reach from children and pets.

• March 17, 2022: New fact sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health (PDF, 491 KB) - This new fact sheet includes information on the medical device shortages authority and work on shortages undertaken in the FDA’s Center for Devices and Radiological Health (CDRH).

• March 16, 2022: MCMi email - New Medical Countermeasures Initiative report and COVID-19 response infographic

• 

  March 16, 2022: FDA published the MCMi Program Update report which showcases FDA's work each year to prepare for all types of public health emergencies, including COVID-19. This report, covering fiscal year 2021, includes an update on FDA's COVID-19 response during the reporting period, and a new infographic [ARCHIVED] providing a snapshot of some FDA COVID-19 response actions from the beginning of the public health emergency through the end of FY 2021.

• March 10, 2022: FDA Orders Philips Respironics to Notify Patients Regarding the Recall of Certain Breathing Assistance Machines  - FDA issued a notification order (PDF, 371 KB)  to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate. 

• March 10, 2022: On March 4, 2022, FDA authorized an extension (PDF, 33 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 9 months. The vaccine was previously authorized to be stored for up to 6 months. This shelf life extension applies to all batches that have been released to the U.S. market, and that have been held in accordance with the manufacturer’s storage conditions. Vaccines that are authorized under an EUA do not have fixed expiration dates, and their expiration dates may be extended based on data submitted by the manufacturers. Health care providers administering the vaccine should check the company’s website (https://vaxcheck.jnj) to obtain the most up-to-date expiration dates for specific lots of the Janssen COVID-19 vaccine. 

• March 9, 2022: MCMi email - More video FAQs on COVID-19 vaccines | Regulatory science update: 3D tissue chips

• March 2, 2022: MCMi email - COVID-19 testing updates | Revisions to COVID-19 therapeutic EUAs

• March 1, 2022: NASA, the National Institutes of Health (NIH), the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), and FDA announced the award of eight contracts in a multi-agency collaboration to extend longevity of complex in vitro (human) models, such as 3D tissue chips and microphysiological systems, to at least six months. Currently, such chips are viable for about one month, limiting researchers’ ability to track longer-term effects of treatments on tissues using these systems. Results from longer studies could be used to better understand disease models, supporting development of and clinical trial design for a variety of medical countermeasures. 

• March 1, 2022: FDA issued safety communications for 3 COVID-19 tests that people should not use:

  • Do Not Use Certain Celltrion DiaTrust COVID-19 Tests

  • Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests

  • Do Not Use Certain ACON Flowflex COVID-19 Tests

• February 25, 2022: FDA updates Sotrovimab EUA - FDA is continually monitoring how authorized and approved treatments for COVID-19 are affected by changing variants—currently Omicron and the Omicron subvariants.  On February 23, 2022, FDA revised the emergency use authorization for sotrovimab to clarify that sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a variant that is not susceptible to this treatment. However, sotrovimab is currently authorized in all U.S. regions until further notice by FDA. For other limitations and conditions, refer to the EUA (PDF, 375 KB).

• February 24, 2022: FDA authorizes revisions to Evusheld dosing - FDA has revised the EUA (PDF, 899 KB) for Evusheld (tixagevimab co-packaged with cilgavimab) to change the initial dose for the authorized use as pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric patients. Based on the most recent information and data available, Evusheld may be less active against certain omicron subvariants. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose.

• February 24, 2022: HHS news release: HHS Secretary Becerra Highlights Progress Made in Strengthening U.S. Medical Supply Chain and Industrial Base - Health and Human Services Secretary Xavier Becerra issued a new report highlighting the progress that has been made over the past year to strengthen the U.S. public health and medical supply chain and industrial base. The report highlights the U.S. government’s accomplishments in addressing public health and medical supply chain challenges since the beginning of the COVID-19 pandemic, describes how HHS is implementing the recommendations and goals in the National Strategy for a Resilient Public Health Supply Chain, and outlines additional actions the U.S. government can take to build on its progress. Also see the updated FDA page: Executive Order 14017 on America’s Supply Chains

• February 23, 2022: MCMi email - New resource on at-home OTC COVID-19 tests | MCMi job alert: Interdisciplinary scientist

• February 22, 2022: New resource - At-Home OTC COVID-19 Diagnostic Tests

• February 18, 2022: E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results

• February 17, 2022: Vyaire Medical Recalls bellavista 1000 and 1000e Series Ventilators Due to Issues with Software Configurations

• February 17, 2022: FDA welcomed Robert M. Califf, MD, as Commissioner of Food and Drugs.

• February 17, 2022: 3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System - FDA is announcing a virtual public workshop on March 16-17, 2022, in collaboration with the Veteran’s Health Administration (VHA) to share VHA’s experiences using 3D printing/additive manufacturing in their hospitals. The workshop is also intended to provide a forum for VHA and other stakeholders to present and discuss their experience that could be useful for health care facilities considering 3D printing medical devices. To attend, register by March 14, 2022. 

• February 16, 2022: MCMi email - FDA authorizes new monoclonal antibody that retains activity against omicron | Feb. 22 webinar on transition plans for COVID-19 medical devices

• February 11, 2022: New web page from FDA's Center for Biologics Evaluation and Research (CBER): International Engagements to Respond to COVID-19 Pandemic

• February 11, 2022: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 That Retains Activity Against Omicron Variant - FDA issued an EUA (PDF, 181 KB) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate. 

• February 11, 2022: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age - FDA has been notified by Pfizer that new data have recently emerged regarding its EUA request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization. Therefore, the FDA is postponing the Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for Feb. 15. 

• February 9, 2022: MCMi email - COVID-19 test safety alert | Using real-world evidence to advance COVID-19 medical countermeasures

• February 8, 2022: Because of significant concerns for human safety, FDA issued a guidance, COVID-19 Public Health Emergency: Policy on COVID-19-Related Sanitation Tunnels, to announce a policy discouraging sponsors from developing or seeking approval or authorization for the use of sanitation tunnels, which are tunnels, walkways, chambers, and similar systems that spray humans with a mist of disinfectant or aerosolized antiseptic with the aim of preventing or treating COVID-19.  

• February 7, 2022: Using real-world evidence to advance COVID-19 medical countermeasures - The rapid assessment of inpatient treatments has emerged as particularly critical for effective COVID-19 care, because the majority of life-threatening cases of COVID-19 are treated in inpatient settings. An FDA-funded extramural research project aims to develop a system of studies for the rapid assessment of the safety and effectiveness of COVID-19 inpatient medical countermeasures using real-world evidence (RWE). 

• February 4, 2022: FDA issued a guidance, Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic, to help sponsors mitigate the challenges related to the constrained supply of nonhuman primates (NHPs) available for conducting nonclinical toxicity assessments, which has arisen as a consequence of the current COVID-19 pandemic.

• February 4, 2022: COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics - The Reagan-Udall Foundation for the FDA, at the request of the FDA, has released a report that outlines initial lessons learned from the federal government’s and research communities’ COVID-19 response and provides actionable recommendations to enhance the scope, prioritization, and communication of research activities within the context of a public health emergency. 

• February 4, 2022: FDA announced that the comment period for the draft guidance: Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act, published on January 11, 2022, has been extended by 30 days, and will close on April 11, 2022. 

• February 2, 2022: New web page from FDA's Center for Veterinary Medicine: From House Cats to Big Cats: How FDA Evaluated Methods for Detecting SARS-CoV-2 in Animals

• February 2, 2022: MCMi email - FDA approves 2nd COVID-19 vaccine | Feb. 15 advisory committee scheduled

• February 1, 2022: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age  - The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session on Feb. 15 to discuss the request for EUA of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.

• January 31, 2022: FDA Takes Key Action By Approving Second COVID-19 Vaccine - The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older. Spikevax meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval. Moderna COVID-19 Vaccine has been available under Emergency Use Authorization (EUA) for individuals 18 years of age and older since Dec. 18, 2020.

• January 28, 2022: Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication - FDA issued a safety communication warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the potentially higher risk of false results when using unauthorized tests. Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, and the FDA has identified this issue as a class I recall, the most serious type of recall.

• January 26, 2022: MCMi email - FDA takes actions to expand use of treatment for outpatients with mild-to-moderate COVID-19 | At-home diagnostic test updates

• January 24, 2022: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant - As we have throughout the COVID-19 pandemic, FDA has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind. Ensuring that healthcare providers on the frontlines have the best tools available to treat patients is a top priority for the agency. In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.  

• January 21, 2022: FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19 - FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization.

• January 19, 2022: UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel - FDA updated the device shortage list to include all blood specimen collection tubes (product codes GIM and JKA) to the testing supplies and equipment – specimen collection category on the device shortage list. The list previously included sodium citrate (light blue top) tubes only. The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time. The FDA will continue to update the list as the COVID-19 public health emergency evolves. To mitigate ongoing shortages, FDA is providing blood specimen collection tube conservation strategies. Also see: Blood Specimen Collection Tube Shortage: Frequently Asked Questions

• January 19, 2022: MCMi email - Video FAQs about COVID-19 vaccines | Apply by Jan. 21 for regulatory science funding

• January 13, 2022: FDA 2021 Year in Review (PDF, 5.9 MB) - This year-end report highlights key FDA actions in 2021 to protect and improve public health, including a COVID-19 vaccine approval and authorizations of COVID-19 tests and treatments. 

• January 12, 202: MCMi email - COVID-19 response updates: tests, vaccines, events, and more

• January 11, 2022: FDA announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (PDF, 1.5 MB) and the Fact Sheet for Recipients and Caregivers (PDF, 776 KB). These revisions are in response to new safety information regarding the serious risk of Immune Thrombocytopenia (ITP), a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets, following administration of the Janssen COVID-19 Vaccine.

• January 11, 2022: Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication

• January 7, 2022: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months - FDA amended the EUA for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older. 

• January 5, 2022: MCMi email - Boosters are now authorized for people 12 years of age and older

• January 3, 2022: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine - FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to: 1) expand the use of a single booster dose to include use in individuals 12 through 15 years of age; 2) shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months; and 3) allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age. Also see: Do I qualify for a COVID-19 vaccine booster and which one?

2021 and earlier

• For news from 2021, please visit this archive page

• For news from 2020, please visit this archive page

• For news from 2019, please visit this archive page

• For news from September 6 - December 31, 2018, please visit this archive page

• For news from January 1 - September 5, 2018, please visit this archive page 

• For news from 2017, please visit this archive page 

• For news from 2010 - 2016, please visit this archive page 

Related links

• MCMi Events Archive

• FDA Newsroom
• MCM-Related Guidance by Date