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/09-12-2022T08:18/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
- FDA has posted the FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. For funding consideration in FY 2023, submit white papers by 5:00 p.m. EST, January 23, 2023. A recording of the FDA BAA Day held on December 6, 2022, will be posted soon.
-
December 8, 2022: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age
-
December 7, 2022: MCMi email - FDA approves first fecal microbiota product | COVID-19 therapeutic EUA updates
-
November 30, 2022: FDA Announces Bebtelovimab is Not Currently Authorized in Any U.S. Region
-
November 28, 2022: FDA approved a new indication (PDF, 244 KB) for Udenyca (pegfilgrastim-cbqv) to increase survival of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS) as could occur after a radiological or nuclear event.
- 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).
-
December 8, 2022: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age - FDA amended the EUAs of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age.
-
December 7, 2022: MCMi email - FDA approves first fecal microbiota product | COVID-19 therapeutic EUA updates
-
December 5, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld, from 18 months to 30 months. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 here). This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 694 KB) and the EUA Letter of Authorization (PDF, 293 KB).
-
November 30, 2022: FDA Announces Bebtelovimab is Not Currently Authorized in Any U.S. Region - FDA announced that bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize omicron subvariants BQ.1 and BQ.1.1., according to data included in the EUA Fact Sheet for Healthcare Providers (PDF, 763 KB).
-
November 30, 2022: MCMi email - FDA authorizes a COVID-19 and flu point-of-care test | FDA & NIST advanced manufacturing collaboration
-
November 28, 2022: FDA approved a new indication (PDF, 244 KB) for Udenyca (pegfilgrastim-cbqv) to increase survival of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS) as could occur after a radiological or nuclear event. Udenyca is the fifth FDA-approved medical countermeasure and first biosimilar that is indicated to increase survival in patients exposed to myelosuppressive doses of radiation. For more information, see the product label (PDF, 460 KB).
-
November 23, 2022: New Just a Minute! video: What does the future hold for FDA’s efforts to address COVID? (YouTube)
-
November 22, 2022: FDA granted an EUA amendment (PDF, 347 KB) to add dizziness to all of the Pfizer-BioNTech COVID‑19 Vaccine Fact Sheets and to update the Fact Sheet for Healthcare Providers Administering Vaccine for 6 months through 4 Years of Age Dilute Before Use (PDF, 2.5 MB) to include new information on effectiveness of a 3-dose primary series in study participants 6 months through 4 years of age.
-
November 22, 2022: FDA issued an EUA (PDF, 302 KB) for the Lucira COVID-19 and Flu Test for use in a point-of-care (POC) setting, following collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP).
-
November 22, 2022: MCMi email - Advanced manufacturing updates | Fast facts for health care providers: bivalent COVID-19 vaccines
-
November 21, 2022: The OCET Advanced Manufacturing Program aims to help FDA develop regulatory science tools and metrics, and facilitate industry adoption of these emerging technologies—especially to improve public health emergency response and supply chain resilience. Today, the Office of Counterterrorism and Emerging Threats (OCET), in the Office of the Chief Scientist, published a new website section with additional information about its advanced manufacturing program, including new pages about the I-TEAM Hub collaboration with HHS/ASPR, a smart design and manufacturing pilot program, and a partnership with the National Institute of Standards and Technology (NIST) to develop and benchmark methods to predict thermal stability of monoclonal antibodies. The section also includes new pages about advanced manufacturing research and projects, and public-private partnerships. The existing Advanced Manufacturing page will continue to include advanced manufacturing news, events, and funding opportunities from across FDA.
- November 17, 2022: New Just a Minute! video - Are the new bivalent COVID-19 vaccines safe? (YouTube)
- November 16, 2022: New fact sheet - Fast Facts for Health Care Providers: Data Points on the Bivalent COVID-19 Vaccination (PDF, 203 KB)
- November 16, 2022: MCMi email - New funding opportunities | COVID-19 and monkeypox response updates | Modeling & simulation at FDA
- November 16, 2022: FDA published a new report, Successes and Opportunities in Modeling & Simulation for FDA. Computational modeling and simulation are powerful tools that complement traditional methods for gathering evidence about products regulated by FDA. FDA scientists routinely review results from M&S studies submitted by industry and use M&S approaches for scientific research and regulatory decision-making. This report presents a selection of modeling and simulation case studies from across FDA, illustrating how these technologies are playing an important role in helping FDA protect and promote public health.
- November 15, 2022: FDA issued an EUA (PDF, 254 KB) to Roche Molecular Systems, Inc. for the cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (EUA220459) for the qualitative detection of DNA from monkeypox virus in human lesion swab specimens from individuals suspected of monkeypox virus infection by their health care provider. 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. Also see: Monkeypox Emergency Use Authorizations for Medical Devices
- November 15, 2022: FDA posted an updated Pfizer-BioNTech COVID-19 Vaccine Presentations Wall Chart (PDF, 596 KB)
- November 15, 2022: FDA collaborated with MITRE to update the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, a resource to help health care delivery organizations prepare for cybersecurity incidents. The playbook focuses on preparedness and response for medical device cybersecurity issues that impact the functionality of a medical device.
- November 9, 2022: MCMi email - Why should I get the updated COVID-19 vaccine now? + COVID-19 therapeutics 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 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 held December 14, 2022.
-
December 15, 2022: Workshop: Efficacy of Monoclonal Antibodies in the Context of Rapidly Evolving SARS-CoV-2 Variants (virtual, 7:00 - 11:00 a.m. EST) - Hosted by FDA and the European Medicines Agency (EMA) to bring together scientists, clinicians, industry representatives and regulators to discuss alternative strategies to support the development of novel monoclonal antibody therapies including those based on prototype products that have demonstrated safety and efficacy in clinical trials. This meeting is intended for experts in the field and/or people actively involved in the topic of the meeting. Please register in advance.
-
December 16, 2022: Machine Learning in Distributed Data Networks like the FDA Sentinel System: Opportunities, Challenges, and Considerations (12:30 - 1:30 p.m. ET, virtual) - To discuss various opportunities for machine learning in distributed data networks like the FDA Sentinel System that conduct activities in pharmacoepidemiology and pharmacovigilance and the unique challenges and considerations they face when applying such methods.
-
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.
Previous events: MCMi Events Archive
General information
-
COVID.gov - Find COVID-19 guidance for your community (a U.S. government website)
-
COVID-19 Resources for Health Professionals (updated Oct. 2022)
-
Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
-
COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
-
FDA COVID-19 response infographic (through Sept. 2021)
-
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)
-
COVID-19 Bivalent Vaccine Boosters (new, August 2022)
-
Fast Facts for Health Care Providers: Data Points on the Bivalent COVID-19 Vaccination (PDF, 203 KB) (new, Nov. 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
- 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.
- November 9, 2022: Funding opportunity - Innovation Award: COVID-19 and Health Equity - FDA's Office of Minority Health and Health Equity (OMHHE) has posted a funding opportunity for to COVID-19 research that will strengthen and advance research in minority health and healthy equity, increase understanding of health disparities, and provide future direction for research that will contribute to regulatory decision making. OMHHE is interested in research proposals that will contribute to advancing understanding of COVID and long COVID or post-COVID conditions for racial and ethnic minorities or contribute to informing the continued evaluation of the safety and efficacy of FDA approved products (therapeutics, diagnostics, and vaccines) for the treatment, prevention, or diagnosis of COVID-19. These research proposals should support evaluation of outcomes by demographic data including, but not limited to, ethnicity, race, age, disability and geography. Letters of intent are due by December 6, 2022, and applications are due by January 16, 2023.
- 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.
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