MCMi News and Events
Medical countermeasure and public health emergency news and events from FDA and partners
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On this page: MCM-related news | Events | COVID-19 resources | Funding opportunities | Connect with us
Featured news and events
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COVID-19 updates from FDA, including the latest news, FAQs, and more
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On April 25, 2023, FDA will host a virtual Public Meeting on Patient-Focused Drug Development for Long COVID, with live translation in English and Spanish. To attend, please register.
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On April 24-28, 2023, FDA will host a training course, Achieving Data Quality and Integrity in Maximum Containment Laboratories (Maryland or virtual). Register now: in-person pre-registration closes March 10, 2023, and virtual pre-registration closes April 14, 2023.
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Job opening: Regulatory Counsel (PDF, 322 KB) - Join the FDA Office of Counterterrorism and Emerging Threats (OCET), offering legal, regulatory, and policy expertise to help support medical countermeasure development and availability. Applications are due by March 15, 2023 (deadline extended).
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March 8, 2023: FDA permits marketing (PDF, 253 KB) of first COVID-19 antigen test using traditional premarket review process
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March 8, 2023: MCMi email - Advanced manufacturing updates | Register now for March and April events
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February 24, 2023: FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses
- February 2023: New! MCMi Fiscal Year 2022 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 (1.5 MB).
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March 8, 2023: FDA permits marketing of first COVID-19 antigen test using traditional premarket review process - FDA granted marketing authorization (PDF, 253 KB) of the Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, intended for prescription use only for the detection of the COVID-19 virus within 6 days of symptom onset and which can be used in a point-of-care setting. The test aids in the diagnosis of COVID-19 for people experiencing symptoms and is to be repeated twice over three days with at least 48 hours between tests.
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March 8, 2023: MCMi email - Advanced manufacturing updates | Register now for March and April events
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March 7, 2023: CDRH Statement on Emergency Use Authorization of Lucira Health’s COVID-19 & Flu Home Test
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March 2, 2023: FDA issued a draft guidance, Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens. This guidance provides drug manufacturers with recommendations for developing and implementing potency assays to ensure each lot of monoclonal antibodies (mAbs) or other therapeutic proteins is produced consistently with the potency necessary to achieve efficacy and that potency is maintained over the shelf life of the product. In January 2021, FDA published a guidance specific to potency considerations for mAbs and therapeutic proteins targeting SARS-CoV-2 (the virus causing COVID-19). This draft guidance expands the scope of the January 2021 guidance to include all mAbs and other therapeutic proteins targeting viruses, not just mAbs targeting SARS-CoV-2. Submit comments by May 1, 2023.
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March 1, 2023: FDA issued the ICH final guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products and a discussion paper for stakeholder comment, Discussion Paper: Artificial Intelligence in Drug Manufacturing (PDF, 1.7 MB). These documents represent proactive steps FDA is taking to facilitate the pharmaceutical industry’s adoption of these advanced manufacturing technologies. FDA has long supported advanced manufacturing technologies that might improve process quality and address underlying causes of drug shortages and recalls. FDA is asking interested stakeholders to provide input on certain areas of consideration identified in the discussion paper by May 1, 2023.
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March 1, 2023: MCMi email - FDA authorizes first over-the-counter at-home test to detect both influenza and COVID-19 viruses
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February 27, 2023: FDA's Center for Drug Evaluation and Research (CDER) Division of Applied Regulatory Science published its 2022 Annual Report (PDF, 7 MB), including COVID-19 research updates.
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February 24, 2023: FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses - FDA issued an EUA (PDF, 290 KB) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes.
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February 24, 2023: FDA recently issued EUAs for two additional over-the-counter (OTC) at-home COVID-19 antigen tests: the GenBody COVID-19 Ag Home Test (PDF, 310 KB, manufactured by GenBody, Inc.), and the COVI-Go SARS-CoV-2 Ag Self-Test (PDF, 382 KB, manufactured by Mologic, Inc.). Validation data to support authorization of these tests were gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between FDA and NIH.
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February 22, 2023: On February 3, 2023, FDA approved a shelf-life extension of TPOXX (tecovirimat) Injection, 200 mg, from 24 months to 42 months for some lots of TPOXX injection. TPOXX supplied by the Strategic National Stockpile (SNS) does not have an expiration date printed on its label. To determine the expiration date for product received from the SNS, find the lot number on the product label and refer to this table to identify the corresponding expiration date. For additional information, see: Expiration Dating Extension: Mpox and Smallpox Therapeutics.
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February 22, 2023: MCMi email - COVID-19 EUA updates | Join us for a March 9 Grand Rounds on microphysiological systems and Zika research
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February 15, 2023: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 24 months to 30 months. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.4 MB) and the Letter of Authorization (PDF, 375 KB). The extended expiry date for each lot can be found in Table 1 here. For additional information, see: Expiration Dating Extension: COVID-19 Therapeutics.
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February 15, 2023: MCMi email - New report: Learn how FDA supports development of & access to medical countermeasures
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February 15, 2023: MCMi Fiscal Year 2022 Program Update - FDA plays a critical role in protecting the United States from chemical, biological, radiological, and nuclear threats, and emerging infectious diseases, like COVID-19 and mpox. This report provides updates on fiscal year 2022 activities FDA-wide to support medical countermeasure-related public health emergency preparedness and response. View the PDF (1.5 MB).
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February 10, 2023: FDA issued an EUA (PDF, 299 KB) for the Cepheid Xpert Mpox test for use in a point-of-care (POC) setting. Validation data was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The Xpert Mpox test is a real-time polymerase chain reaction (PCR) test intended to detect monkeypox virus DNA in lesion swab specimens from individuals suspected of mpox by their health care provider.
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February 10, 2023: Update on Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles (PDF, 221 KB) - On February 1, 2023, FDA issued a memo to government public health and emergency response stakeholders providing an important update about expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules manufactured by West-Ward Pharmaceuticals held in strategic stockpiles for anthrax emergency preparedness and response purposes. Also see: Expiration date extensions of certain lots of doxycycline hyclate
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February 9, 2023: FDA updates draft guidance to help increase supply of children’s ibuprofen - FDA has revised the immediately-in-effect guidance on compounding certain ibuprofen oral suspension products. The revision addresses outsourcing facilities providing certain ibuprofen oral suspension products to state-licensed pharmacies (including those within hospitals and health systems) and applicable federal facilities to dispense to patients for home use, following receipt of a valid, patient-specific prescription from a health care provider. FDA published this revision to address continual increased demand for fever and pain-reducing medications outside of hospitals and health systems.
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February 8, 2023: Summary report (PDF, 110 KB) of the Dec. 2022 Joint EMA-FDA workshop on the efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants
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February 8, 2023: MCMi email - Report your COVID-19 at-home test results | Now hiring: Regulatory Counsel
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 mpox) - FDA will host regular town halls to share information and answer questions from attendees. Recordings of previous webinars on the policy for mpox tests are available from CDRH Learn, under Specialty Technical Topics. The next event in this series will be March 22, 2023.
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March 9, 2023: FDA Grand Rounds: Microphysiological Systems as Novel Disease Models and Drug Development Tools - This presentation by researchers from FDA's National Center for Toxicological Research (NCTR) evaluates a testicular organoid model for use as an in vitro model of Zika virus infection.
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March 14, 2023: FDA CBER Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop (virtual) - For FDA staff and cell and gene therapy stakeholders to discuss innovative manufacturing technologies and alternative testing methods, and share experiences, challenges, and best practices critical for chemistry, manufacturing, and controls (CMC) of cellular and gene therapies and tissue engineered medical products. Please register in advance.
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March 16, 2023: Antimicrobial Drugs Advisory Committee meeting (virtual) - The committee will meet in open session to discuss a New Drug Application (NDA) for Paxlovid (nirmatrelvir and ritonavir co-packaged tablets) for oral use. The proposed indication is treatment of mild-to-moderate coronavirus disease (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is currently authorized for emergency use.
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March 28-29, 2023: Public Workshop: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review (virtual) - Hosted by FDA and the Duke-Robert J. Margolis, MD Center for Health Policy, to understand the priorities for the development of Digital Health Technologies (DHTs) to support clinical drug trials, including accessibility, diversity, and clinical outcomes measures using DHTs.
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March 30, 2023: Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation Public Workshop (virtual) - Immune globulins (IGs) are used extensively to treat primary and secondary antibody deficiencies, and a variety of autoimmune diseases. The purpose of the workshop is to gain insight and to identify measures to prevent hypersensitivity reactions associated with specific lots of IG. Register to attend.
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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. Registration is now open.
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April 24-28, 2023: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Maryland or virtual) - This popular course offers a unique opportunity for the regulatory and scientific communities to discuss complex issues in an interactive environment and identify and share best practices for ensuring data quality and integrity in BSL-4 facilities, including hands-on training for in-person attendees. Register now: in-person pre-registration closes March 10, 2023 (space is limited), and virtual pre-registration closes April 14, 2023.
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April 25, 2023: Public Meeting on Patient-Focused Drug Development for Long COVID (virtual) - To provide FDA the opportunity to obtain initial patient and patient representative input on the aspects of Long COVID, including how Long COVID affects their daily life, symptoms that matter most to patients, their current approaches to treating Long COVID, and what they consider when determining whether or not to participate in a clinical trial. This virtual public meeting will be conducted with live translation in both English and Spanish. To attend, please register.
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April 25-26, 2023: FDA - United States Pharmacopeia (USP) Asia-Pacific Economic Cooperation (APEC) Medical Product Supply Chain Dialogue (Rockville, MD or webcast) - To bring international medical product regulators, multilateral organization representatives, and industry and academic professionals together, to discuss public health priorities, the impact of the COVID-19 pandemic on supply chains, and why the APEC Supply Chain Security Toolkit (PDF, 6.4 MB) continues to be a valuable tool to stakeholders.
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May 11-12, 2023: Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop (Silver Spring, MD or virtual) - To provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. Seating is limited to approximately 250 attendees and will be available on a first come, first served basis. Attendees can indicate their interest to attend in person during the free registration for this workshop and are encouraged to register early.
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June 13-14, 2023: 2023 FDA Science Forum (virtual) - Topic areas for this virtual event include medical countermeasures, infectious disease and pathogen reduction technologies (session 6), and product development and manufacturing, including advanced manufacturing (session 4). Registration is now open.
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-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
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FAQs: What happens to EUAs when a public health emergency ends?
Vaccines
- Why should I get the updated COVID-19 vaccine now?
- More Video Frequently Asked Questions: Just a Minute! videos with Dr. Peter Marks on YouTube
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The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723 KB)
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)
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Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
Testing
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FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. You can report your test result by going to MakeMyTestCount.org or by using an app or other digital option for self-reporting that may be included with your test.
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Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
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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
- 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.
- 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.
Connect with us
View previous editions of the MCMi email newsletter
For more information
MCMi
- MCMi News Archive - MCMi news from 2010 to the present
- MCMi Events Archive - MCMi events from 2010 to the present
- Publications and Reports - including annual MCMi program updates
Emergency use
- Emergency Use Authorization (all current EUAs, including information about amendments)
- Expiration Dating Extension (including the Shelf Life Extension Program, and product-specific information)
- Emergency Use Authorizations (devices)
- MCM Emergency Use Authorities (information about, including EUA)
- Emergency Dispensing Orders and Emergency Use Instructions (EUI)
Guidance and industry information
- MCM-Related Guidance by Date (including comment deadlines, where applicable)
- Guidance and Other Information of Special Interest to MCM Stakeholders (by topic)
- Search for FDA Guidance Documents
Public health emergency response updates and MCM-related issues
- FDA Mpox Response
- Antimicrobial resistance information from FDA
- Ebola Preparedness and Response
- FDA/DoD Collaborations
- Preparedness Information for Consumers
- More topic-specific pages, including radiological and nuclear emergency preparedness, smallpox preparedness, pediatric MCMs, and MCM monitoring and assessment
Product shortages and availability
- Drug Shortages
- CBER-Regulated Products: Shortages and Discontinuations (vaccines, blood, biologics)
- Drug Shortages Database
- How to report a product shortage or supply issue to FDA
More FDA news and events
- FDA Newsroom - press announcements, fast facts, speeches, and more
- FDA Voices - perspectives from FDA experts