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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On April 27, 2023, BARDA and FDA will host a virtual Recombinant Protein-Based COVID-19 Vaccines Workshop
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April 26, 2023: MCMi email - Join FDA and BARDA April 27 for a workshop: Recombinant Protein-Based COVID-19 Vaccines
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April 19, 2023: Draft guidance for industry: Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment
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April 18, 2023: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines
- 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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April 26, 2023: MCMi email - Join FDA and BARDA April 27 for a workshop: Recombinant Protein-Based COVID-19 Vaccines
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April 19, 2023: FDA announced availability of a draft guidance for industry, Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment. The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule. Submit comments by July 19, 2023.
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April 19, 2023: MCMi email - FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines | New EUA for COVID-19 at-home test
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April 18, 2023: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines - FDA amended the EUAs of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
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April 14, 2023: HHS Fact Sheet: HHS Announces Intent to Amend the Declaration Under the PREP Act for Medical Countermeasures Against COVID-19 - The end of the COVID-19 public health emergency alone does not automatically terminate PREP Act coverage for countermeasures. This fact sheet explains some of the key planned changes that partners can expect regarding PREP Act coverage as well as some of what will not change in the coming weeks.
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April 12, 2023: Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication - FDA is recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks manufactured by O&M Halyard.
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April 5, 2023: FDA issued a draft guidance, Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making. This guidance is the fourth in a series of guidance documents intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision-making. This guidance is intended to help clinical trial sponsors in medical product development. The guidance focuses on clinical outcome assessments (COA) issues associated with clinical trial (study) endpoints, design, conduct and analysis and is most relevant to those designing and conducting trials using COAs as well as analyzing and interpreting the trial data. Submit comments by July 5, 2023.
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April 5, 2023: FDA announced the availability of a draft guidance to help prevent and mitigate drug shortages: Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients (API) Under Section 506C of the FD&C Act. The purpose of this guidance is to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain APIs that may, in turn, help the agency in its efforts to prevent and mitigate drug shortages. While some supply disruptions and product shortages cannot be predicted or prevented, early communication and detailed notifications to FDA from manufacturers play a significant role in decreasing the incidence, impact, and duration of supply disruptions and product shortages. These notifications allow the agency to evaluate the situation and determine an appropriate course of action. Submit comments by June 5, 2023.
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April 5, 2023: MCMi email - FDA authorizes a new COVID-19 treatment for certain hospitalized adults | Last chance to pre-register for data quality in BSL-4 labs course
View more news in the MCMi News Archive
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April 27, 2023: Recombinant Protein-Based COVID-19 Vaccines Workshop (virtual, 9:00 a.m. - 1:00 p.m. ET) - Hosted by the Biomedical Advanced Research and Development Authority (BARDA) and FDA, to provide: 1) a forum for product sponsors to discuss progress and technical challenges in the manufacturing when changing strain composition to currently circulating variants of SARS-CoV-2; and 2) an open forum for collaborative discussions to facilitate advancement of recombinant protein-based COVID-19 vaccines.
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May 4, 2023: Public Webinar Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making – Draft Guidance (1:00 - 3:00 p.m. ET) - For patients, industry, and other interested stakeholders to discuss and answer questions about the draft guidance.
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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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May 18, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual) - The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine), manufactured by Pfizer Inc., with a requested indication, in Biologics License Application (BLA) 125768 (STN 125768/0), for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals.
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June 5-9, 2023: Regulatory Education for Industry (REdI) Annual Conference 2023 - Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities. Please register in advance.
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June 8, 2023: Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches (Washington, DC or virtual) - Convened by the Duke-Margolis Center for Health Policy under a cooperative agreement with FDA, to support the utilization of innovative manufacturing technologies for drugs and biological products.
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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
- April 2023: RFI open to solicit ideas for ARPA-H, FDA collaboration - The Advanced Research Projects Agency for Health (ARPA-H) is seeking unique and creative ideas on how to best collaborate with the Food and Drug Administration to encourage and incentivize public-private partnerships in the health ecosystem, with the goal of accelerating better health outcomes for everyone. Interested persons and organizations are invited to submit comments on or before 5:00 p.m. ET on May 30, 2023. Early submissions are encouraged as materials will be reviewed on a rolling basis.
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