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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Register now to attend the 2023 FDA Science Forum (virtual) June 13-14, 2023
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May 31, 2023: FDA approved a second vaccine for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years and older
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May 31, 2023: MCMi email - FDA approves first oral antiviral for treatment of COVID-19 in adults
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May 23, 2023: FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria
- MCMi Fiscal Year 2022 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 (1.5 MB).
- June 1, 2023: On May 22, 2023, Janssen Biotech, Inc. requested the voluntary withdrawal of the EUA of the Janssen COVID-19 Vaccine. Janssen Biotech, Inc. informed the FDA that the last lots of the vaccine purchased by the U.S. Government have expired, there is no demand for new lots of the vaccine in the U.S., and they do not intend to update the strain composition of this vaccine to address emerging variants. On June 1, 2023, FDA revoked the EUA (PDF, 100KB) for this vaccine. Also see: Emergency Use Authorization--Archived Information
- May 31, 2023: FDA approved a second vaccine for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years and older
- May 31, 2023: Hurricane Emergency Preparedness and Medical Devices: Recommendations for Health Care Providers, Device Manufacturers and Distributors (new web page)
- May 31, 2023: MCMi email - FDA approves first oral antiviral for treatment of COVID-19 in adults
- May 25, 2023: FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults - FDA approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults. Paxlovid manufactured and packaged under the EUA and distributed by HHS will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by today’s approval. Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19. Also see these updated resources: Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers (PDF, 323 KB), Frequently Asked Questions on the EUA for Paxlovid for Treatment of COVID-19 (PDF, 349 KB), and Fact Sheet for Healthcare Providers: EUA for Paxlovid (PDF, 724 KB), (new) approved product label (PDF, 5.1 MB)
- May 24, 2023: MCMi email - Improving medical product manufacturing capacity and flexibility: new VHA & FDA collaboration
- May 23, 2023: FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria - FDA approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older. According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines.
- May 22, 2023: FDA and the Veterans Health Administration announced a new collaboration to jointly develop emergency preparedness and response tools and protocols intended to help increase medical product manufacturing capacity and flexibility, and improve resilience of domestic supply chains during emergencies, shortages, and pandemics. A new Memorandum of Understanding (MOU) will help facilitate the development of requirements for trusted networks needed to enable the use of distributed manufacturing and digital stockpiles, which could ultimately enable veterans and civilians to more rapidly access innovative medical products to support their care. Learn more, including descriptions of these advanced manufacturing approaches.
- May 17, 2023: FDA issues two draft guidances for industry to support the approval of pediatric drug products - FDA issued two draft guidances for industry entitled, Pediatric Drug Development: Regulatory Considerations – Complying with PREA and Qualifying for Pediatric Exclusivity Under the BPCA and Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations. Both guidances, once finalized, will provide recommendations to support the assessment of pediatric drugs, biological products, and vaccines under the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). The guidance documents revise and replace the draft guidance for industry How to Comply with the Pediatric Research Equity Act. Comments on both draft guidances are due by July 17, 2023.
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May 17, 2023: MCMi email - COVID-19 end of PHE reminders | AI discussion paper
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May 12, 2023: Eleventh Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 - On May 9, 2023, HHS Secretary Becerra signed the 11th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures. The Secretary issued this amendment to clarify that COVID-19 continues to pose a credible risk of a future public health emergency, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, and extend the duration of the Declaration to December 31, 2024.
- May 12, 2023: FDA updated information on medical device shortages to reflect the end of the COVID-19 public health emergency (PHE), including providing answers to questions regarding notifications and guidance under Section 506J of the FD&C Act.
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May 11, 2023: DSCSA Exemptions From Certain Requirements Under Section 582 of the FD&C Act for Covered COVID-19 Products (PDF, 323 KB) - In an effort to transition after the end of the COVID-19 PHE and to avoid potential supply chain disruptions that could harm the COVID-19 response and recovery, FDA has granted the exemptions listed in the document from certain requirements under section 582 of the FD&C Act, as added by the Drug Supply Chain Security Act (DSCSA). FDA has determined that these exemptions are appropriate to maintain public health and has determined that these exemptions address prescription drug products approved or authorized by FDA to diagnose, cure, mitigate, treat, or prevent COVID-19.
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May 11, 2023: Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies - As we reflect on the devastating losses and lasting impacts the COVID-19 pandemic has had worldwide, we will use the lessons we’ve learned to be thoughtful about preparing for future public health emergencies and use the knowledge gained from our experience with COVID-19 to inform our future response efforts.
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May 10, 2023: FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing - As with other evolving fields of science and technology, there are challenges associated with AI/ML in drug development, such as ethical and security considerations like improper data sharing or cybersecurity risks. There are also concerns with using algorithms that have a degree of opacity, or algorithms that may have internal operations that are not visible to users or other interested parties. This can lead to amplification of errors or preexisting biases in the data. We aim to prevent and remedy discrimination — including algorithmic discrimination, which occurs when automated systems favor one category of people over other(s) — to advance equity when using AI/ML techniques. To address these concerns, the FDA has released a discussion paper, Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products (PDF, 1.3 MB). Sumit comments by August 9, 2023. To further address the use of AI in drug manufacturing, in February 2023, FDA issued another discussion paper, Artificial Intelligence in Drug Manufacturing (PDF, 1.7 MB), as part of the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative.
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May 10, 2023: MCMi email - End of COVID-19 public health emergency updates | FDA approves first RSV vaccine
View more news in the MCMi News Archive
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June 5-9, 2023: Regulatory Education for Industry (REdI) Annual Conference 2023 - Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities. Please register in advance.
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June 8, 2023: Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches (Washington, DC or virtual) - Convened by the Duke-Margolis Center for Health Policy under a cooperative agreement with FDA, to support the utilization of innovative manufacturing technologies for drugs and biological products.
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June 8, 2023: Antimicrobial Drugs Advisory Committee meeting (virtual) - The committee will meet in open session to discuss biologics license application (BLA) 761328, for nirsevimab, a long-acting respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody for intramuscular use, submitted by AstraZeneca AB. The proposed indication is prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
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June 13-14, 2023: 2023 FDA Science Forum (virtual) - Topic areas include medical countermeasures, infectious disease and pathogen reduction technologies, and product development and manufacturing, including advanced manufacturing. See the full agenda (PDF, 196 KB), and register now to attend. Don't miss the 200+ posters!
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June 15, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign.
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June 20, 2023: Decentralized Clinical Trials (DCT) Draft Guidance webinar (3:00 - 4:00 p.m. ET) - As part of FDA’s efforts to be responsive to the rapidly evolving clinical trial landscape and clarify the Agency’s recommendations on the conduct of DCTs, FDA will provide an overview of the draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices.
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September 26-27, 2023: FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing (virtual) - This workshop, hosted by FDA and the Product Quality Research Institute (PQRI), aims to facilitate interaction among AI stakeholders on critical areas for development, implementation, and regulatory consideration including uses in process development and control, operation of Pharmaceutical Quality Systems, lifecycle approaches, and Current Good Manufacturing Practice. Registration will open in Summer 2023.
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September 28-29, 2023: Complex In Vitro Model (CIVM) Qualification Framework Public Workshop (Bethesda, MD) - Hosted by the Critical Path Institute (C-Path) Predictive Safety Testing Consortium, with stakeholders from FDA, academia, model developers, and the pharmaceutical industry, this workshop aims to form a consensus on model standards and features to improve performance of liver CIVMs as a tool for drug development and regulatory assessment. The meeting will also include sessions to discuss system optimization and cell sourcing, model validation and performance, and defining contexts of use to address unmet needs in regulatory decision making. Please register in advance.
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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COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
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FAQs: What happens to EUAs when a public health emergency ends?
Vaccines
- Why should I get the updated COVID-19 vaccine now?
- More Video Frequently Asked Questions: Just a Minute! videos with Dr. Peter Marks on YouTube
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The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723 KB)
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)
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Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
Testing
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FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. You can report your test result by going to MakeMyTestCount.org or by using an app or other digital option for self-reporting that may be included with your test.
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Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
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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
- April 2023: RFI open to solicit ideas for ARPA-H, FDA collaboration - The Advanced Research Projects Agency for Health (ARPA-H) is seeking unique and creative ideas on how to best collaborate with the Food and Drug Administration to encourage and incentivize public-private partnerships in the health ecosystem, with the goal of accelerating better health outcomes for everyone. Interested persons and organizations are invited to submit comments on or before 5:00 p.m. ET on May 30, 2023. Early submissions are encouraged as materials will be reviewed on a rolling basis.
Connect with us
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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)
- 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
- FDA Mpox Response
- Antimicrobial resistance information from FDA
- Ebola Preparedness and Response
- FDA/DoD Collaborations
- Preparedness Information for Consumers
- More topic-specific pages, including 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