MCMi News and Events
Medical countermeasure and public health emergency news and events from FDA and partners
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Featured news and events
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Coronavirus Disease 2019 (COVID-19) updates from FDA, including the latest news, FAQs, and more
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August 31, 2022: MCMi email - FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose | Media call today at 10:45 a.m. ET
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August 31, 2022: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose - Also see: COVID-19 Bivalent Vaccine Boosters (new page)
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August 26, 2022: FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply
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August 26, 2022: FDA updated the Paxlovid Patient Eligibility Screening Checklist and Drug Interaction Tool (PDF, 995 KB) for prescribers, to add additional drugs
- 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).
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September 2, 2022: FDA posted new Just a Minute! videos with CBER Director Dr. Peter Marks including, What is in the authorized updated (bivalent) COVID-19 boosters? and Why should I get one of the updated COVID-19 vaccine boosters?
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September 2, 2022: In August, FDA approved a New Drug Application (NDA) for the use of Midazolam Injection, 10 mg/0.7 mL, autoinjector, for the treatment of status epilepticus in adults. The Department of Defense (DoD) developed the product with Rafa Laboratories, Ltd. According to JPEO-CBRND (the U.S. Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense), the autoinjector "improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA) diazepam autoinjector." For more information, see the NDA approval letter (PDF, 302 KB) and product label (PDF, 913 KB).
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September 1, 2022: FDA posted new Just a Minute! videos with CBER Director Dr. Peter Marks including, What is a bivalent vaccine? and What data support the use of the updated COVID-19 boosters?
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September 1, 2022: FDA Voices: Using A Whole-Of-Governments Approach to Combating Illicit Health Products, including fraudulent COVID-19 products
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August 31, 2022: MCMi email - FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose | Media call today at 10:45 a.m. ET
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August 31, 2022: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose - FDA amended the EUAs of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines, which we will also refer to as “updated boosters,” contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older. Also see: COVID-19 Bivalent Vaccine Boosters (new page)
With this authorization, FDA has also revised the EUAs of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older, respectively. These monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older as described in the letters of authorization. -
August 29, 2022: Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Monkeypox Virus and HCT/P Donation
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August 26, 2022: FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply - FDA announced the removal of N95 respirators from the agency’s medical device shortage list, signaling that demand or projected demand for this type of face protection device commonly used in health care settings no longer exceeds the supply. This action is the result of increased domestic manufacturing of N95 respirators, as well as updates to the FDA’s supply chain assessment based on engagement with industry and federal stakeholders, and the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health’s (NIOSH) approval of new disposable N95s and reusable respirators. Also see: Supplies of Medical Devices for COVID-19: Frequently Asked Questions
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August 26, 2022: FDA updated Frequently Asked Questions on the Emergency Use Authorization of Bebtelovimab for the Treatment of COVID-19 (PDF, 953 KB) to revise information about distribution of this product.
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August 26, 2022: FDA updated the Fact Sheet for Health Care Providers (PDF, 1.5 MB) for Lagevrio (molnupiravir) to link to the most current information for health care providers related to medical conditions and factors associated with increased risk for progression to severe COVID-19.
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August 26, 2022: FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this time (a listing of additional resources is provided at the end of the checklist). Please see the updated Paxlovid Patient Eligibility Screening Checklist and Drug Interaction Tool (PDF, 995 KB) for more information.
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August 26, 2022: The material threat medical countermeasure priority review voucher (MCM PRV) web page has been updated to include a table listing redeemed MCM PRVs.
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August 25, 2022: FDA's Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) published its Fiscal Year 2021 Report on the State of Pharmaceutical Quality (PDF, 1.1 MB) to provide information on the quality of the U.S. drug supply and OPQ’s quality surveillance during COVID-19.
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August 24, 2022: MCMi email - Check your COVID-19 test expiration dates | Monkeypox response updates from FDA
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August 22, 2022: Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to Monkeypox Virus
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August 19, 2022: Sentinel Initiative report: Differences in COVID-19 Testing, Positivity, Hospitalization, and Mortality by Race and Ethnicity in the Sentinel Distributed Database: A Descriptive Analysis
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August 19, 2022: FDA authorized the emergency use (PDF, 913 KB) of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age. This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA. The agency previously authorized the vaccine for individuals 18 years and older. Also see the updated fact sheets for recipients/caregivers (PDF, 703 KB) and health care providers (PDF, 1.2 MB).
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August 18, 2022: Monkeypox response: FDA Fast Facts: Jynneos (PDF, 222 KB) is now also available in Chinese (Simplified) (PDF, 698 KB), Korean (PDF, 708 KB), Spanish (PDF, 679 KB), Tagalog (PDF, 669 KB), and Vietnamese (PDF, 769 KB).
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August 18, 2022: Intradermal Jynneos Monkeypox Vaccine Fast Facts (PDF, 200 KB)
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August 18, 2022: Report: FDA's Work to Combat the COVID-19 Pandemic (PDF, 4.9 MB) - Outlines much of the broad range of work the FDA is undertaking to combat the COVID-19 pandemic and prepare for future emergencies.
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August 17, 2022: National Center for Toxicological Research (NCTR) Research Highlight: Monitoring SARS-CoV-2 and Its Variants in Arkansas Wastewater
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August 17, 2022: MCMi email - COVID-19 and monkeypox response updates from FDA | Monkeypox vaccine fact sheet in multiple languages
View more news in the MCMi News Archive
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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
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September 8, 2022: FDA Grand Rounds: Polio Vaccines: Past, Present and the Future (webcast, 12:00 - 1:00 p.m. ET) - To discuss the evolution of vaccines against poliomyelitis driven by the change in disease epidemiology, socio-economic circumstances, and advances in biotechnology.
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September 12-13, 2022: DIA-USFDA-PMDA-TGA-CDSCO Advanced Manufacturing Workshop (virtual, 5:30 - 9:30 a.m. EDT) - Embracing The Future: Regulatory Considerations And Industry Perspectives On Advanced Manufacturing - FDA's India Office and the Drug Information Association (DIA) India Office will host a two-day workshop on regulatory policies, guidance and support for the adoption of advanced manufacturing technologies.
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September 14, 2022: An Overview of Sentinel’s Publicly Available Analytics Tools webinar (12:00 p.m. ET) - This webinar will explore the resources available in Sentinel for individuals unfamiliar with Sentinel’s analytics tools and the Sentinel Common Data Model. Please register in advance.
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September 19, 2022: FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs (virtual) - The workshop will focus on comparative clinical studies associated with biosimilar development programs and will discuss possible innovative ideas that have the potential to streamline and improve the efficiency of biosimilar development. Advance registration required.
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September 20-22, 2022: 2022 Center for Biologics Evaluation and Research (CBER) Science Symposium (12:00 - 4:00 p.m. ET, virtual) - To discuss scientific topics related to the regulation of biologics and highlight science conducted at CBER by showcasing how scientific research informs regulatory decision making, and to provide a forum for developing collaborations within FDA and with external organizations. Advance registration required.
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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.
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September 22, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 5:00 p.m. ET) - The committee will meet in open session to discuss the Biologics License Application # 125739 (BLA - 125739) from Rebiotix Inc. for a product, Rebyota (Fecal Microbiota, Live), with a requested indication to reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI.
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September 27, 2022: FDA Drug Topics: Development and U.S. Regulation of Preventative Vaccines (webinar, 1:00 - 2:15 p.m. ET) - To provide an overview of the development and federal regulations for vaccines in the United States, including key statutes that grant FDA authority to regulate vaccines, precipitating historical events, and current regulatory requirements for vaccine licensure and marketing approval.
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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.
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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.
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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.
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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.
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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.
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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.
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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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Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
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COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
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Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals
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FDA COVID-19 response infographic (through Sept. 2021)
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FAQs: What happens to EUAs when a public health emergency ends?
Vaccines
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COVID-19 Bivalent Vaccine Boosters (new, August 2022)
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COVID-19 Vaccine Boosters: Getting the Facts Straight (podcast, April 2022)
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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)
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Learn More About COVID-19 Vaccines (Consumer Update)
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5 Things You Need to Know about the COVID-19 Vaccine for Adolescents 12 through 17 (Consumer Update)
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The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723 KB)
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#VaccineReady Social Media Toolkit with resources in English and Spanish, from FDA's Office of Minority Health and Health Equity
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)
Testing
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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
- 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.
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MCMi
- MCMi News Archive - MCMi news from 2010 to the present
- MCMi Events Archive - MCMi events from 2010 to the present
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Emergency use
- Emergency Use Authorization (all current EUAs, including information about amendments)
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Guidance and industry information
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Public health emergency response updates and MCM-related issues
- Antimicrobial resistance information from FDA
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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