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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COVID-19 updates from FDA, including the latest news, FAQs, and more
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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 February 24, 2023.
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February 1, 2023: FDA revised the Letters of Authorization for two EUAs, Paxlovid and Lagevrio, to remove the requirement for positive COVID-19 test results to prescribe these products.
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February 1, 2023: MCMi email - COVID-19 therapeutics update: Evusheld not currently authorized in U.S. | Watch out for illegally sold mpox products
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January 31, 2023: FAQs: What happens to EUAs when a public health emergency ends? (updated)
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January 26, 2023: Emergent Recalls Certain RSDL (Reactive Skin Decontamination Lotion) Kits Due to Leak Potential
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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.
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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).
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February 6, 2023: Job opening - Regulatory Counsel (PDF, 322 KB) (Title 21, Cures Band C) - 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 February 24, 2023.
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February 6, 2023: 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. Report each test result only one time. Learn more: Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
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February 3, 2023: FDA granted marketing authorization of the BioFire SPOTFIRE Respiratory (R) Panel, a diagnostic test used for the simultaneous detection and identification of multiple respiratory viral and bacterial infections in individuals suspected of having COVID-19 or other respiratory tract infections. This test was cleared through the Dual 510(k) and CLIA Waiver pathway, making it the first COVID-19 test to be given a CLIA Waiver.
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February 1, 2023: FDA revised the Letters of Authorization for two EUAs, Paxlovid (PDF, 283 KB) and Lagevrio (PDF, 286 KB), to remove the requirement for positive test results to prescribe these products. The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19. However, we recognize that, in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, their health care provider may determine that treatment with authorized therapeutics may be appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high risk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions of the product’s authorization are met. Additional information is available on the EUA page.
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February 1, 2023: FDA issued a draft guidance for industry, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products. This guidance makes recommendations to sponsors and investigators considering the use of externally controlled clinical trials to show evidence of the safety and effectiveness of a drug. The guidance provides stakeholders with considerations for designing and conducting externally controlled trials that use patient-level data (i.e., information on individual people, such as medical and treatment history) to study the effectiveness and safety of drugs, including threats to the validity of trial results from sources of potential bias. The external data can include data from other clinical trials or from real-world data sources such as registries, electronic health records, or medical claims. This guidance also describes considerations for communicating with FDA and ensuring the agency has access to data from an externally controlled trial. This draft guidance is part of a series of guidances FDA has already published, or plans to publish, as part of the agency’s Real-World Evidence Program and in support of the 21st Century Cures Act and the Prescription Drug User Fee Act. Submit comments by May 2, 2023.
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February 1, 2023: MCMi email - COVID-19 therapeutics update: Evusheld not currently authorized in U.S. | Watch out for illegally sold mpox products
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January 31, 2023: FAQs: What happens to EUAs when a public health emergency ends? (updated)
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January 31, 2023: FDA published a new web page, Illegally Sold Monkeypox (Mpox) Products, and issued warning letters to five companies illegally selling products that claim to cure, treat, mitigate, or prevent human monkeypox (mpox) infection. Images of these products are available on Flickr.
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January 26, 2023: FDA announces Evusheld is not currently authorized for emergency use in the U.S. - FDA revised the EUA (PDF) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision, Evusheld is not currently authorized for use in the U.S. until further notice by the Agency.
Should a patient become infected with SARS-CoV-2 and develop symptoms of COVID-19, they should seek medical attention, including starting treatment for COVID-19 as appropriate. There are several treatments – Paxlovid, Veklury (remdesivir) and Lagevrio (molnupiravir) – that are expected to work against currently circulating variants, and that are authorized or approved to treat certain patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Health care providers should assess whether treatments are right for their patients. Also see: Important prescribing information for health care providers (PDF, 135 KB)
The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 769 KB) and the Letter of Authorization (PDF, 286 KB). Also see: Expiration Dating Extension - COVID-19 Therapeutics -
January 26, 2023: Emergent Recalls Certain RSDL Kits Due to Leak Potential - Emergent is recalling RSDL (Reactive Skin Decontamination Lotion) kits from a specific batch after customers noted that some packets were leaking. The leak in the package could cause the lotion-bearing sponge to be less effective when used to remove or neutralize chemical warfare agents. Users also may be unnecessarily exposed to the lotion from leaked packages. The RSDL kit is an easy-to-open packet containing a sponge soaked with lotion. The RSDL kit is carried by members of the military and is intended to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries and/or serious health consequences.
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January 25, 2023: MCMi email - Developers of drug and biological products for mpox: new draft guidance | Jan. 26 VRBPAC viewing info
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.
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February 8, 2023: The House Committee on Energy and Commerce; Subcommittees on Oversight and Investigations and Health will hold a hearing, The Federal Response to COVID-19 (10:00 a.m. ET). FDA Commissioner Dr. Robert M. Califf will testify along with other leaders from across HHS.
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February 9, 2023: FDA Grand Rounds: A Modular Approach for Enhanced Plasmid Subtyping and AMR Gene Profiling of Plasmids (webcast, 12:00 - 1:00 p.m. ET) - Plasmids are a major factor in the spread of antimicrobial resistance genes. Current plasmid typing methods do not account for the great degree of genetic diversity associated with the recombination mechanisms that allow plasmids to acquire antimicrobial resistance genes. In this presentation, Lucas Harrison, Ph.D., FDA Center for Veterinary Medicine (CVM), introduces an enhanced plasmid subtyping method that not only identifies the genetic elements exclusive to and indicative of a plasmid type, but also characterizes plasmids based on the DNA sequence and relative position of these genetic elements as they are rearranged through plasmid recombination mechanisms.
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February 28-March 1, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of two respiratory syncytial virus (RSV) vaccine Biologics License Applications (BLAs).
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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) - Save the date! Registration will open in February 2023.
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June 13-14, 2023: Save the date for the 2023 FDA Science Forum! Topic areas for this virtual event include medical countermeasures, infectious disease and pathogen reduction technologies, and product development and manufacturing, including advanced manufacturing.
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? (YouTube, Nov. 2022)
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COVID-19 Bivalent Vaccine Boosters (new, August 2022)
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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 (new, Dec. 2022)
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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.
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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
- Antimicrobial resistance information from FDA
- Ebola Preparedness and Response
- FDA/DoD Collaborations
- Preparedness Information for Consumers
- More topic-specific pages, including Zika virus, 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