• 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. 

• January 26, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss the future vaccination regimens addressing COVID-19, including consideration of the composition and schedule of the primary series and booster vaccinations. Also see: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19

• 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 by Lucas Harrison, Ph.D., FDA Center for Veterinary Medicine (CVM), we introduce 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. 

• 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. 

• 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

• COVID.gov - Find COVID-19 guidance for your community (a U.S. government website)

• Coronavirus Disease 2019 (COVID-19)

• COVID-19 Frequently Asked Questions

• COVID-19 Resources for Health Professionals 

• Multilingual COVID-19 Resources

• COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders

• FAQs: What happens to EUAs when a public health emergency ends?

Vaccines

• COVID-19 Vaccines

• Why should I get the updated COVID-19 vaccine now? (YouTube, Nov. 2022)

• COVID-19 Bivalent Vaccine Boosters (new, August 2022)

• Vaccine Development – 101

• Emergency Use Authorization for Vaccines Explained

• Vaccine EUA Questions and Answers for Stakeholders

• The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723 KB)

Therapeutics

• Know Your Treatment Options for COVID-19 

• An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program

• CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19

• FDA Updates on Paxlovid for Health Care Providers (May 2022)

• Why You Should Not Use Ivermectin to Treat or Prevent COVID-19

Testing

• Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results (new, Dec. 2022)

• Coronavirus Testing Basics

• At-Home OTC COVID-19 Diagnostic Tests

• A Closer Look at COVID-19 Diagnostic Testing (for health care providers, test purchasers, and public health staff)

• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests

• Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs

• In Vitro Diagnostics EUAs

Regulatory science

• FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available

• 3D Printing in FDA’s Rapid Response to COVID-19

• Investing in Advanced Manufacturing to Support Public Health Preparedness

• Wastewater Surveillance for SARS-CoV-2 Variants

• 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 17, 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.