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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May 10, 2023: MCMi email - End of COVID-19 public health emergency updates | FDA approves first RSV vaccine
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May 9, 2023: From HHS: Fact Sheet: End of the COVID-19 Public Health Emergency
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May 3, 2023: FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
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May 2, 2023: FDA Takes Additional Steps to Advance Decentralized Clinical Trials
- 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).
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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
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May 9, 2023: If you missed the April 27, 2023, Recombinant Protein-Based COVID-19 Vaccines Workshop, a recording is now available until June 15, 2023.
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May 9, 2023: From HHS: Fact Sheet: End of the COVID-19 Public Health Emergency - Based on current COVID-19 trends, the Department of Health and Human Services (HHS) is planning for the federal Public Health Emergency (PHE) for COVID-19, declared under Section 319 of the Public Health Service (PHS) Act, to expire at the end of the day on May 11, 2023. This fact sheet includes an update on current flexibilities enabled by the COVID-19 emergency declaration and how they will be impacted by the end of the COVID-19 PHE on May 11.
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May 5, 2023: FDA permits marketing of first COVID-19 serology tests through de novo pathway - FDA granted marketing authorization of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack for use with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack for use with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator, both manufactured by Ortho-Clinical Diagnostics, Inc. These tests are intended for prescription use only for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma samples collected on or after 15 days post-symptom onset as an aid in identifying individuals who have an adaptive immune response to SARS-CoV-2 from either a recent or prior infection. Serology tests detect the presence of antibodies to SARS-CoV-2 and do not detect the virus itself. This is one reason that serology tests should not be used to diagnose or exclude acute COVID-19 infection. The sensitivity of the tests in early infection is unknown. Negative results do not mean that the tested individual is free from an acute SARS-CoV-2 infection. If acute infection is suspected, diagnostic testing, such as a PCR or antigen test for COVID-19, is necessary.
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May 5, 2023: FDA launched a new web page, Antimicrobial Resistance and Medical Devices, to explain how antimicrobial susceptibility test devices are intended to help health care providers identify the correct therapy (antimicrobial agent) to treat specific bacterial or fungal infections and help identify drug-resistant infections for patient care. Antimicrobial susceptibility testing devices sold in the U.S. for use in clinical laboratories must be reviewed and cleared by the FDA’s Center for Devices and Radiological Health (CDRH).
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May 4, 2023: FDA Commissioner Dr. Robert Califf and other HHS officials testified at a U.S. Senate Committee on Health, Education, Labor & Pensions hearing, Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act.
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May 3, 2023: FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine - FDA approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. In older adults, RSV is a common cause of lower respiratory tract disease, which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). According to the U.S. Centers for Disease Control and Prevention (CDC), each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older.
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May 3, 2023: MCMi email - Updates on antimicrobial resistance, device cybersecurity, COVID-19 vaccines and tests + more
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May 2, 2023: FDA Takes Additional Steps to Advance Decentralized Clinical Trials - FDA is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites. The agency released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research. Examples of decentralized elements include obtaining laboratory tests at a local facility rather than a research medical center or conducting a clinical follow-up visit in the trial participant’s home using telemedicine. Submit comments on the draft guidance by August 1, 2023. Also see: CDER Conversation: The Evolving Role of Decentralized Clinical Trials and Digital Health Technologies
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May 1, 2023: FDA released a new video, Tips for Health Care Facilities: Cybersecurity Incident Preparedness and Response, featuring Dr. Mark Jarrett, Chief Quality Officer from Northwell Health, with the key focus on how to prepare for a cybersecurity event and how to ensure patient safety during a prolonged cybersecurity event. The video also points viewers to supplementary materials on the FDA website to help health care facilities plan. Also see the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, a resource to help health care organizations prepare for medical device cybersecurity incidents that impact device functions.
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April 28, 2023: New video: Meet FDA's Chief Scientist, Dr. Namandjé Bumpus (3 minutes)
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April 26, 2023: MCMi email - Join FDA and BARDA April 27 for a workshop: Recombinant Protein-Based COVID-19 Vaccines
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April 19, 2023: FDA announced availability of a draft guidance for industry, Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment. The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule. Submit comments by July 19, 2023.
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April 19, 2023: MCMi email - FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines | New EUA for COVID-19 at-home test
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April 5, 2023: FDA issued a draft guidance, Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making. This guidance is the fourth in a series of guidance documents intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision-making. This guidance is intended to help clinical trial sponsors in medical product development. The guidance focuses on clinical outcome assessments (COA) issues associated with clinical trial (study) endpoints, design, conduct and analysis and is most relevant to those designing and conducting trials using COAs as well as analyzing and interpreting the trial data. Submit comments by July 5, 2023.
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April 5, 2023: FDA announced the availability of a draft guidance to help prevent and mitigate drug shortages: Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients (API) Under Section 506C of the FD&C Act. The purpose of this guidance is to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain APIs that may, in turn, help the agency in its efforts to prevent and mitigate drug shortages. While some supply disruptions and product shortages cannot be predicted or prevented, early communication and detailed notifications to FDA from manufacturers play a significant role in decreasing the incidence, impact, and duration of supply disruptions and product shortages. These notifications allow the agency to evaluate the situation and determine an appropriate course of action. Submit comments by June 5, 2023.
View more news in the MCMi News Archive
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May 11, 2023: FDA Commissioner Dr. Robert Califf and other HHS officials will testify at a U.S. House Energy & Commerce Health Subcommittee hearing, Preparing for and Responding to Future Public Health Security Threats (10:00 a.m. ET).
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May 11-12, 2023: Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop (Silver Spring, MD or virtual) - To provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. Seating is limited to approximately 250 attendees and will be available on a first come, first served basis. Attendees can indicate their interest to attend in person during the free registration for this workshop and are encouraged to register early.
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May 18, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual) - The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine), manufactured by Pfizer Inc., with a requested indication, in Biologics License Application (BLA) 125768 (STN 125768/0), for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals.
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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 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 13-14, 2023: 2023 FDA Science Forum (virtual) - Topic areas for this virtual event include medical countermeasures, infectious disease and pathogen reduction technologies (session 6), and product development and manufacturing, including advanced manufacturing (session 4). Registration is now open.
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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.
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
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
- 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