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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Meeting - November 30, 2021: Antimicrobial Drugs Advisory Committee (AMDAC) meeting - To discuss Merck and Ridgeback’s request for an EUA for molnupiravir, an investigational antiviral drug to treat COVID-19.
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November 10, 2021: MCMi email - Fighting COVID-19 with science | More OTC diagnostic tests authorized
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October 29, 2021: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age
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October 20, 2021: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines - listen to a media call on these actions with Acting FDA Commissioner Janet Woodcock, MD, and FDA CBER Director Peter Marks, MD, PhD
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MCMi Fiscal Year 2020 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 (4.3 MB).
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November 10, 2021: MCMi email - Fighting COVID-19 with science | More OTC diagnostic tests authorized
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November 3, 2021: MCMi email - COVID-19 vaccine authorized for 5-11-year-olds | FDA investigating certain imported medical gloves
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November 2, 2021: Alcohol-based Hand Sanitizer: Drug Safety Communication - Getting in the Eyes Can Cause Serious Injury - FDA is warning that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye. Eye exposure to hand sanitizer has been reported in all age groups; however, it has occurred most often in children. Such eye injuries have become much more frequent, likely due to the marked increase in the use of alcohol-based hand sanitizer during the COVID-19 pandemic.
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October 29, 2021: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age - FDA authorized (PDF, 428 KB) the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization (PDF) was based on the FDA's thorough and transparent evaluation of the vaccine that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group. More information: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
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October 29, 2021: FDA is investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new. The FDA has determined that many foreign manufacturers and shippers of medical gloves have failed to consistently provide medical gloves of adequate quality for distribution in the United States. The FDA recommends that health care facilities and providers do not purchase or use imported medical gloves from companies included on Import Alert 80-04 Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves. If you have purchased any medical gloves that are visibly soiled, are a different color, appear to have been used, or otherwise seem to be fraudulent, please report it to the FDA by email to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.
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October 29, 2021: FDA announced the new use of a NextGen Portal for reporting the annual amount of listed human and animal drugs and human biological products that an establishment manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for commercial distribution. All registrants of drug establishments or their authorized agents should use the portal to submit annual reports as required under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, as added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Links to the portal, draft guidances, and other relevant information are available at: Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts.
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October 27, 2021: MCMi email - Increasing availability of over-the-counter COVID-19 tests | Are you eligible for a COVID-19 booster shot?
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October 26, 2021: 'Chipping’ Away at Personalized Medicine (from NASA) - A collaboration among NASA, FDA, the National Institutes of Health (NIH), and the HHS Office of the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority (BARDA) aims to extend the longevity of 3D tissue chips and microphysiological systems to a minimum of six months. Results from longer-duration studies could be used to better understand disease models, drug development, clinical trial design, chemical and environmental exposures and countermeasures, and physiological changes due to the spaceflight environment.
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October 22, 2021: FDA and HHS ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for the refrigerated Eli Lilly monoclonal antibody, etesevimab, which is currently authorized for emergency use only when administered together with bamlanivimab. As a result of this extension, unopened vials of etesevimab, injection, 700 mg/20 mL, should be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F), and may be stored for an additional 6 months from the labeled date of expiry (See Table 1 here). FDA granted this extension following a thorough review of data submitted by Eli Lilly. This extension applies to all unopened vials of etesevimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 737 KB) and the Letter of Authorization (PDF, 488 KB) for Emergency Use Authorization (EUA) 094 for bamlanivimab and etesevimab, administered together.
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October 20, 2021: MCMi email - FDA takes additional actions on the use of a booster dose for COVID-19 vaccines
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October 20, 2021: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines - FDA took additional actions regarding booster doses of COVID-19 vaccines, including authorizing heterologous (or “mix and match”) booster doses in certain individuals following completion of primary vaccination with a different available COVID-19 vaccine. Listen to a media call on these actions with Acting FDA Commissioner Janet Woodcock, MD, and FDA CBER Director Peter Marks, MD, PhD.
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October 14, 2021: Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-CoV-2 Test Results - Abbott Molecular, Inc. is recalling Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits because they have the potential to give false positive results when used to detect SARS-CoV-2. For these tests, a “false positive” is a test result that indicates that a person has the virus when they do not actually have it. The recall described in this notice is due to the same issue that was announced in the September 17, 2021 Letter to Health Care Providers: Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits.
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October 14, 2021: FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment - FDA is announcing an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback’s request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19. On November 30, 2021, the advisory committee will meet to discuss the available data supporting the use of molnupiravir to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who have tested positive for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
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October 13, 2021: FDA Voices: FDA’s Advanced Manufacturing Initiatives Helping to Provide Quality Human Drugs for Patients - FDA has long recognized the importance of advanced manufacturing. The FDA has received significant funding from Congress for advanced manufacturing-related projects, and we continue to work with manufacturers looking to implement these new technologies to benefit even more patients. To do so, the Center for Drug Evaluation and Research (CDER) has established numerous initiatives, including the development of a research program to better understand the science of advanced manufacturing. To date, this program has fueled nearly 60 research projects, including many collaborations with experts in the field.
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October 13, 2021: FDA announced the availability of a draft ICH guidance for industry titled Q13 Continuous Manufacturing of Drug Substances and Drug Products. The guidance, which was prepared under the support of the International Council for Harmonisation (ICH), describes scientific and regulatory considerations for the development, implementation, and operation of continuous manufacturing.
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October 13, 2021: MCMi email - COVID-19 vaccine myths: busted
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 2021.
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November 3-4, 2021: BARDA Industry Day (virtual) - Registration is open, and the full agenda is now available. FDA's Elizabeth Sadove, JD, will present on emergency use authorities.
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November 8 - 9, 2021: 13th Annual Sentinel Initiative Public Workshop - This virtual public workshop will highlight milestones and strategic initiatives underway to enhance and build a more robust Sentinel Initiative. Stakeholders will discuss opportunities to utilize Sentinel’s existing data, infrastructure, and technology.
- November 9, 2021: FDA CERSI Lecture on Long COVID: Risk factors, Symptomology and Patient Reported Outcomes, presented by by Dr. Erica Spatz & Dr. Kelli O’Laughlin, 3:00 - 4:00 p.m. ET (virtual)
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November 16, 2021: Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA) (virtual) - To provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss enhanced drug distribution security requirements of the DSCSA related to system attributes necessary to enable secure tracing of product at the package level. (FR notice)
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November 30, 2021: Antimicrobial Drugs Advisory Committee (AMDAC) meeting - To discuss Merck and Ridgeback’s request for an EUA for molnupiravir, an investigational antiviral drug to treat COVID-19. The committee will discuss the available data supporting the use of molnupiravir to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who have tested positive for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
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December 7-8, 2021: Clinical Investigator Training Course (CITC) Update, including a review of the development and emergency use authorization of medical products for the prevention and treatment of COVID-19, and investigator responsibilities during the pandemic.
Previous events: MCMi Events Archive
General information
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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
Vaccines
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Multilingual COVID-19 Vaccines Myths Social Media Toolkit (new, September 2021)
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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
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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September 29, 2021: FDA Office of Minority Health and Health Equity (OMHHE) announces a new funding opportunity: COVID-19 and Health Equity Innovation Award - OMHHE continues to work to promote and protect the health of racial and ethnic minorities, underrepresented and underserved populations through research and communication strategies that address health disparities. The COVID-19 and Health Equity Innovation award helps support this work. Applications are due by November 29, 2021.
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June 1, 2021: The National Aeronautics and Space Administration (NASA) is soliciting science investigations for Extended Longevity of 3D Tissues and Microphysiological Systems for Modeling of Acute and Chronic Exposures to Stressors (3DTANDMPS). This multi-agency solicitation is sponsored by NASA’s Human Exploration and Operations Mission Directorate (HEOMD)’s Human Research Program (HRP), the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS), the NIH National Institute of Allergy and Infectious Diseases (NIAID), the NIH National Cancer Institute (NCI), the Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA), and the FDA, to solicit for research in support of common cross-organizational goals. This NRA is focused on adapting existing 3D tissues and microphysiological systems (MPS), also known as “tissue chips” or “organs-on-chips,” to extend the current longevity of the 3D tissues and MPS to at least 6 months. All non-governmental organizations are eligible to apply. A pre-proposers conference (PDF, 120 KB) will be held on June 8, 2021. The Step 1 deadline is June 28, 2021.
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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)
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Guidance and industry information
- MCM-Related Guidance by Date (including comment deadlines, where applicable)
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- 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