MCMi News and Events
Medical countermeasure and public health emergency news and events from FDA and partners
![News & events text shown on typewriter](https://public4.pagefreezer.com:443/content/FDA/04-10-2022T10:19/https://www.fda.gov/files/styles/main_image_medium/public/news-events-1600px_0.jpg?itok=hj8AJRGh)
Featured news and events
-
Coronavirus Disease 2019 (COVID-19) updates from FDA, including the latest news, FAQs, and more
-
October 3, 2022: Latest information and updates about Evusheld for PrEP for COVID-19
-
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
- 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 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:
-
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 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: FDA Commissioner Dr. Robert Califf testified before the U.S. Senate Committee on Health, Education, Labor & Pensions hearing: Stopping the Spread of Monkeypox: Examining the Federal Response
-
September 14, 2022: MCMi email - FDA takes significant action to help expand access to monkeypox testing | COVID-19 response updates from FDA
View more news in the MCMi News Archive
-
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. The town hall events scheduled for October 5 and 12, 2022 will be on the topic of monkeypox only. Recordings of previous webinars on the policy for monkeypox tests are available from CDRH Learn, under Specialty Technical Topics.
-
October 5, 2022: Study Data Standards Update for CBER: Your Guide to a Successful Submission (webcast, 1:00 - 2:00 p.m. ET) - CBER will discuss CBER’s support and requirement starting March 15, 2023 for the Standard for the Exchange of Nonclinical Data (SEND), which was published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog.
-
October 6, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 12:40 p.m. ET) - The committee will meet in open session to discuss strain selection for influenza virus vaccines for the 2023 Southern Hemisphere influenza season.
-
October 11, 2022: FDA NanoDay Symposium 2022 (webinar) - To address drug development of products that contain nanomaterials in their formulation and how the guidance to industry for products that contain nanomaterials finalized in April 2022 can be implemented in filings to the FDA. Discussion will include case studies on the development of the COVID mRNA lipid nanoparticle vaccine products.
-
October 13, 2022: FDA Grand Rounds - Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins (webcast, 12:00 - 1:00 p.m. ET) - MAM is a liquid chromatography-mass spectrometry based peptide mapping approach used for the identification and quantitation of product quality attributes in therapeutic proteins.
-
October 20, 2022: COVID-19 Evidence Accelerator: What We've Learned, Where We're Headed (webinar, 1:00 p.m. ET) - A public meeting hosted by the Reagan-Udall Foundation for the FDA and Friends of Cancer Research, to highlight accomplishments and share learnings, including how best to leverage real-world data and improve data interoperability, to address current and future health challenges.
-
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.
-
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.
-
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.
-
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 24, 2022.
-
Previous events: MCMi Events Archive
General information
-
COVID.gov - Find COVID-19 guidance for your community (a U.S. government website)
-
Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
-
COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
-
Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals
-
FDA COVID-19 response infographic (through Sept. 2021)
-
FAQs: What happens to EUAs when a public health emergency ends?
Vaccines
-
COVID-19 Bivalent Vaccine Boosters (new, August 2022)
-
COVID-19 Vaccine Boosters: Getting the Facts Straight (podcast, April 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 2022)
-
Learn More About COVID-19 Vaccines (Consumer Update)
-
5 Things You Need to Know about the COVID-19 Vaccine for Adolescents 12 through 17 (Consumer Update)
-
The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723 KB)
-
#VaccineReady Social Media Toolkit with resources in English and Spanish, from FDA's Office of Minority Health and Health Equity
Therapeutics
-
An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program
-
FDA Updates on Paxlovid for Health Care Providers (May 2022)
Testing
-
A Closer Look at COVID-19 Diagnostic Testing (for health care providers, test purchasers, and public health staff)
-
Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs
Regulatory science
-
FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available
-
Investing in Advanced Manufacturing to Support Public Health Preparedness
-
Extramural research, including projects supporting the COVID-19 response
- 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.
- 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.
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
- 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