MCMi News and Events
Medical countermeasure and public health emergency news and events from FDA and partners
Featured news and events
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Coronavirus Disease 2019 (COVID-19) updates from FDA, including the latest news, FAQs, and more
- October 20, 2022: Monkeypox response update: FDA provides lists of laboratories offering notified laboratory-developed tests (LDTs)
- 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 for the detection of SARS-CoV-2.
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October 12, 2022: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups
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October 7, 2022: First commercial test kit authorized for detection of monkeypox
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September 29, 2022: Why is FDA allowing intradermal delivery of the monkeypox vaccine? (new Just a Minute! video with CBER Director Dr. Peter Marks)
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September 27, 2022: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types
- MCMi Fiscal Year 2021 Program Update - FDA and our partners work every day to help facilitate development of and access to safe, effective medical countermeasures to counter emerging threats. Learn more about the steps we're taking to protect national health and security in this report. View the PDF (1.4 MB).
- 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.
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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.
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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.
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September 29, 2022: Why is FDA allowing intradermal delivery of the monkeypox vaccine? (new Just a Minute! video with CBER Director Dr. Peter Marks)
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September 28, 2022: MCMi email - FDA updates COVID-19 test policy | New printable COVID-19 vaccine wall charts including bivalent boosters
View more news in the MCMi News Archive
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Ongoing: Virtual Town Hall Series – Test Development and Validation During Public Health Emergencies (COVID-19 and Monkeypox) - FDA will host regular town halls to share information and answer questions from attendees. Recordings of previous webinars on the policy for monkeypox tests are available from CDRH Learn, under Specialty Technical Topics. The next events in this series will be held October 26, November 9 (monkeypox only), November 30, and December 14, 2022.
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November 9, 2022: Meeting of the Pulmonary-Allergy Drugs Advisory Committee (virtual, 9:00 a.m. - 5:00 p.m. ET) - The committee will discuss the request for EUA 113, for sabizabulin oral capsule, a tubulin polymerization inhibitor, submitted by Veru Inc., for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome.
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November 14-16, 2022: FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement (virtual) - To facilitate interaction among distributed manufacturing (DM)/ point of care (POC) stakeholders on critical areas for development and implementation of DM and POC technologies including terminology, technical challenges to adoption, operation of Pharmaceutical Quality Systems, good manufacturing practice expectations, and the unique challenges and considerations that apply to complex biologics.
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November 15-16, 2022: 14th Annual Sentinel Initiative Public Workshop (virtual) - Hosted by the Duke-Margolis Center for Health Policy under a cooperative agreement with FDA, participants will hear from Sentinel Initiative leadership on a range of key issues including recent studies and applications of Sentinel to protect and promote public health during the COVID-19 pandemic and monkeypox public health emergency.
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November 15-16, 2022: BARDA Industry Day - Save the date! The Biomedical Advanced Research and Development Authority (BARDA), a component of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), invites you to participate in its annual conference to learn about U.S. Government medical countermeasure priorities, interact with the BARDA and ASPR teams, and network with public and private sector colleagues.
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November 17, 2022: FDA Grand Rounds - Medical Extended Reality: Applications and Challenges (webcast, 12:00 - 1:00 p.m. ET) - FDA Physicist and Office of Science and Engineering Laboratories (OSEL) Medical Extended Reality (MXR) Program Coordinator Ryan Beams, Ph.D., will present an overview of augmented and virtual reality technology and of the landscape of potential medical applications. He will also discuss regulatory science efforts to address evaluation challenges for using augmented and virtual reality in medicine.
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December 6, 2022: FDA Broad Agency Announcement Day - FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Join us to learn more about the FY 2023 BAA, and how to apply. We'll post more info as it becomes available.
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December 7-8, 2022: FDA Clinical Investigator Training Course (CITC) 2022 - To promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products.
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April 24-27, 2023: 2023 Preparedness Summit (Atlanta, GA) - The theme, Recover. Renew: Reprioritizing All-Hazards Preparedness, will provide an opportunity to revisit pressing issues in preparedness and share resources, shape policies, and build skills to mitigate a variety of threats. Submit abstracts by October 31, 2022.
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Previous events: MCMi Events Archive
General information
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COVID.gov - Find COVID-19 guidance for your community (a U.S. government website)
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COVID-19 Resources for Health Professionals (updated Oct. 2022)
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Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
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COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
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FDA COVID-19 response infographic (through Sept. 2021)
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FAQs: What happens to EUAs when a public health emergency ends?
Vaccines
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COVID-19 Bivalent Vaccine Boosters (new, August 2022)
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COVID-19 Vaccine Boosters: Getting the Facts Straight (podcast, April 2022)
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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 2022)
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Learn More About COVID-19 Vaccines (Consumer Update)
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5 Things You Need to Know about the COVID-19 Vaccine for Adolescents 12 through 17 (Consumer Update)
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The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723 KB)
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#VaccineReady Social Media Toolkit with resources in English and Spanish, from FDA's Office of Minority Health and Health Equity
Therapeutics
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An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program
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FDA Updates on Paxlovid for Health Care Providers (May 2022)
Testing
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A Closer Look at COVID-19 Diagnostic Testing (for health care providers, test purchasers, and public health staff)
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Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs
Regulatory science
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FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available
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Investing in Advanced Manufacturing to Support Public Health Preparedness
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Extramural research, including projects supporting the COVID-19 response
- October 6, 2022: FDA is seeking applications for Centers of Excellence in Regulatory Science and Innovation (CERSIs), to conduct collaborative regulatory science research and foster information sharing. Letters of intent are due by October 31, 2022, and applications are due by December 22, 2022.
- September 20, 2022: FDA announced a collaboration with NIH for funding opportunities to support small businesses in developing medical device development tools (MDDTs).
- 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: 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.
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Product shortages and availability
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