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The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
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ICYMI: COVID-19 resources
End of PHE updates
On May 11, 2023, the COVID-19 public health emergency (PHE) declared under the Public Health Service Act expired. While the PHE has ended, people are still getting sick from COVID-19, and the virus remains a leading cause of death in the United States. CDC continues to advise that everyone get vaccinated, get an additional vaccine dose if your doctor advises it, use at-home tests if you’ve been exposed or have symptoms, stay home if you’re sick, and wear a high-quality mask when COVID-19 community levels are high. These precautions are the best ways you can protect yourself and your loved ones.
FDA is committed to continuing to use every tool in our toolbox to fight COVID-19, including pivoting as the virus adapts. We’ll continue to post the latest updates at: http://www.fda.gov/covid19.
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Consumer resources
Lessons learned from COVID-19 are informing preparation for future public health emergencies
FDA Voices, by Robert M. Califf, M.D., Commissioner of Food and Drugs and Hilary Marston, M.D., M.P.H., Chief Medical Officer
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. (May 11, 2023)
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Emergency Use Authorization (EUA) updates
Eleventh amendment to declaration under the PREP Act for medical countermeasures against COVID-19
HHS Secretary Becerra signed the 11th amendment to the declaration under the Public Readiness and Emergency Preparedness Act (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. Also see, from HHS: PREP Act Questions and Answers (May 9, 2023)
EUA revocations
FDA revoked the following EUA for the reasons noted in the revocation letter (PDF):
Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.
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Events
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May 18, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual)
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June 5-9, 2023: Regulatory Education for Industry (REdI) Annual Conference 2023 (virtual)
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June 8, 2023: Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches (Washington, DC or virtual)
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June 8, 2023: Antimicrobial Drugs Advisory Committee meeting (virtual)
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June 15, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual)
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New! 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, the FDA will provide an overview of the draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices.
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New! 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.
Learn more about these events, and see more on the MCMi News and Events page, under Upcoming events.
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Information for industry and health care providers
COVID-19 guidance
During the COVID-19 PHE, FDA has provided important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders. We remain committed to providing timely recommendations and regulatory information to support response efforts. The ending of the PHE declared by HHS under the PHS Act will not impact FDA’s ability to authorize devices (including tests), treatments, or vaccines for emergency use. Existing EUAs for products will remain in effect and FDA may continue to issue new EUAs going forward when criteria for issuance are met.
In the Federal Register of March 13, 2023, FDA published a notice addressing the Agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the PHE, and which of those guidance documents FDA is revising to temporarily continue in effect. The web page, COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders, has been updated to list only the COVID-19 guidances that remain in effect at this time. For information on viewing expired or withdrawn guidances, see Archived Guidances. (May 12, 2023)
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Artificial intelligence and machine learning
FDA issued a discussion paper, Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products (PDF). The discussion paper is intended to initiate communication surrounding artificial intelligence and machine learning (AI/ML) with stakeholders, including industry and academia, to promote mutual learning and discussion.
FDA is soliciting feedback on the opportunities and challenges with utilizing AI/ML in drug development and medical device development for drugs. This discussion paper will complement and inform future guidance on AI/ML in drug development. Specifically, the questions in Section B aim to initiate a discussion with stakeholders and solicit feedback on three key areas in the context of AI/ML in drug development. These areas are:
- human-led governance, accountability, and transparency
- quality, reliability and representativeness of data
- model development, performance, monitoring, and validation
For more information, please see the Federal Register notice (comments due by August 9, 2023), and visit: Artificial Intelligence and Machine Learning for Drug Development.
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DSCSA exemptions from certain requirements under Section 582 of the FD&C Act for covered COVID-19 products
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 here (PDF) 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. (May 11, 2023)
Medical device shortage updates
FDA updated information on medical device shortages to reflect the end of the COVID-19 PHE, including providing answers to questions, such as:
- Are 506J (FD&C Act) notifications required now that the COVID-19 PHE declaration expired?
- What is the status of the FDA’s guidance documents related to Section 506J?
- How do I submit voluntary 506J notifications?
FDA continues to work with federal partners and other supply chain stakeholders to help prevent and mitigate shortages of medical devices. FDA will continue to monitor the supply chain and update the device shortage list and device discontinuance list as new information becomes available. (May 12, 2023)
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In case you missed it
What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ (updated May 12, 2023). Also see, from HHS, Fact Sheet: End of the COVID-19 Public Health Emergency
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Update your antibodies
The virus that causes COVID-19 changes over time. Get your updated COVID-19 vaccine to help protect against COVID’s worst outcomes. Search in your zip code to find a location where a bivalent COVID-19 vaccine is available near you.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 400 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.
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