MCMi News and Events
Medical countermeasure and public health emergency news and events from FDA and partners
Featured news and events
-
Coronavirus Disease 2019 (COVID-19) updates from FDA, including the latest news, FAQs, and more
-
July 15, 2022: For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication
-
July 13, 2022: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted
-
July 13, 2022: MCMi email - FDA authorizes pharmacists to prescribe Paxlovid | Advanced manufacturing job openings
-
July 12, 2022: The Office of Counterterrorism and Emerging Threats (OCET) is hiring advanced manufacturing staff fellows for engineering and research positions
-
July 8, 2022: FDA approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 in individuals 12 through 15 years of age (read more)
-
July 6, 2022: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations
- 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).
-
July 15, 2022: For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication
- July 15, 2022: HHS orders additional vaccine, increases testing capacity to respond to monkeypox outbreak (HHS press release) - The FDA recently announced that it has completed its inspection of the Bavarian Nordic manufacturing facility in Denmark. Observations from inspections inform FDA’s evaluation of other quality information submitted by sponsors, which are critical to helping ensure vaccines’ safety and effectiveness. Doses from the facility can potentially be approved by the end of July, which would mean that approximately 780,000 additional doses would be added to the government’s available supply.
-
July 14, 2022: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to include information about genotyping tests authorized for the identification and differentiation of specific SARS-CoV-2 mutations, lineages, or variants.
-
July 13, 2022: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted - FDA issued an EUA (PDF, 899 KB) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. Also see: Novavax COVID-19 Vaccine
-
July 13, 2022: MCMi email - FDA authorizes pharmacists to prescribe Paxlovid | Advanced manufacturing job openings
-
July 12, 2022: Apply to join the Office of Counterterrorism and Emerging Threats (OCET) Advanced Manufacturing team, to help advance public health emergency preparedness and patient access to medical products through development of tools and approaches to enhance the evaluation of advanced manufacturing technologies and facilitate their adoption by regulated industries. Apply by August 1, 2022. For more information see the Staff Fellow job announcements:
-
OCET Research Engineer (PDF, 159 KB) (General Engineer)
-
OCET Research Scientist (PDF, 146 KB) (General Health and Medical Sciences)
-
-
July 8, 2022: FDA approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 15 years of age. The approval follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by FDA. The Pfizer-BioNTech COVID-19 Vaccine has been, and will continue to be, authorized for emergency use in this age group since May 2021. COMIRNATY (COVID-19 Vaccine, mRNA) has been approved for use in individuals 16 years of age and older since August 2021.
-
July 6, 2022: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations - The FDA revised the Emergency Use Authorization (EUA) (PDF, 783 KB) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. Also see: Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment of COVID-19 (PDF, 995 KB)
-
July 6, 2022: MCMi email - COVID-19 vaccine and therapeutic updates | FDA seeking consumer representatives for advisory committees
-
July 1, 2022: FDA is requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. For advisory committee vacancies listed in this notice, and those that may occur through December 31, 2023. Nomination materials are due by August 15, 2022.
-
June 30, 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 29, 2022: FDA authorizes revisions to Evusheld dosing to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection
-
June 29, 2022: MCMi email - Updates from FDA on COVID-19 medical countermeasures, monkeypox testing, advanced manufacturing, and more
View more news in the MCMi News Archive
-
Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - During the virtual town hall, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event. FDA will host additional webinars in this series in 2022
-
July 19-20, 2022: Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites
-
August 11, 2022: 2022 FDA CVM Advanced Manufacturing Public Meeting, 1:00 - 4:00 p.m. EDT - FDA's Center for Veterinary Medicine (CVM) will host a virtual public meeting on the FDA’s oversight of advanced manufacturing technologies for animal drugs. The meeting will be a listening session to provide stakeholders with an opportunity to share information and insight on this topic with CVM. Learn more: FDA Announces Virtual Public Meeting on Advanced Manufacturing for Animal Drugs
-
August 30, 2022: Virtual public workshop - Drug Development Considerations for the Prevention of Healthcare-Associated Infections - FDA and the Centers for Disease Control and Prevention (CDC) are co-sponsoring this workshop to discuss topics including the current state of development of pathogen-directed products used to prevent healthcare-associated infections, and antimicrobial resistance threats as potential targets for decolonization and pathogen reduction. To attend, register by 12:00 p.m. EDT August 29, 2022. Requests to make oral presentations must be received by August 15, 2022.
-
September 21-22, 2022: 2022 Public Meeting of the National Antimicrobial Resistance Monitoring System (NARMS) - FDA, in cooperation with the U.S. Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, its partners in the National Antimicrobial Resistance Monitoring System (NARMS), opened registration for the 2022 Public Meeting of NARMS. The meeting is open to all stakeholders at no cost. The NARMS public meeting will be held virtually on Wednesday, September 21, 2022 from 12:00 p.m. to 5:00 p.m. ET and Thursday, September 22, 2022 from 9:30 a.m. to 4:30 p.m. ET. A virtual technical workshop to demonstrate how to access NARMS data online will be held on Tuesday September 20, 2022 from 9:00 a.m. to 4:00 p.m. ET.
-
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.
-
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 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)
-
Multilingual COVID-19 Vaccines Myths Social Media Toolkit (new, September 2021)
-
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
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