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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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Updated mRNA COVID-19 Vaccines
- On September 11, 2023, FDA took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.
- These actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.
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Related Information
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Guidance updates
- On September 18, 2023, FDA FDA issued the draft guidance, Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence. This guidance (the Confirmatory Evidence guidance) complements the draft guidance for industry Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products (December 2019) and the “Guidance for industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (May 1998).
- On September 15, 2023, FDA issued the draft guidance Labeling for Biosimilar and Interchangeable Biosimilar Products and corresponding Notice of Availability (NOA). In this draft guidance, the FDA outlines its recommendations for biosimilar and interchangeable biosimilar product labeling.
- On September 14, 2023, FDA issued an update to the final guidance: Breakthrough Devices Program. The updates align with the actions outlined in the FDA’s Center for Devices and Radiological Health Strategic Priorities to Advance Health Equity by supporting innovation of new and existing technologies that address health inequities.
- On September 07, 2023, FDA issued the final guidance: Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.This guidance adds, within a new attachment (Attachment G), recommendations which reflect the agency's current thinking about the type of biocompatibility information that should be provided in a medical device premarket submission for certain devices in contact with intact skin. CDRH will host a webinar on Oct. 12, 2023 for industry and others interested in learning more about the guidance.
- On September 06, 2023, FDA issued three draft guidances intended to support efforts to continue to strengthen and modernize the 510(k) Program and advance the safety and effectiveness of medical devices as they become more complex and innovative.
- On September 05, 2023, FDA updated the guidance: Enforcement Policy for Face Masks and Barrier Face Coverings for Coronavirus Disease (COVID-19) Response.
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Emergency Use Authorization (EUA) updates
- On August 28, 2023, FDA announced the availability of a final guidance for industry entitled Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products.
- This guidance discusses the applicability of FDA’s investigational new drug application (IND) regulations under part 312 (21 CFR part 312) to various clinical study designs that utilize RWD and also clarifies the Agency’s expectations concerning clinical studies using RWD submitted to FDA in support of a regulatory decision regarding the effectiveness and safety of a drug (e.g., as part of a new drug application (NDA) or biologics license application (BLA)) when such studies are not subject to part 312.
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Events
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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)
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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.
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October 04-06, 2023: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska) - two and one half-day (2 days for virtual attendees) interactive course allows participants to enhance knowledge and integrate practical considerations for the planning and operation of clinical research protocols involving medical countermeasures for high consequence pathogens. Registration now open
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October 05, 2023: Vaccines and Related Biological Products Advisory Committee meeting to discuss the Strain Selection for the Influenza Virus Vaccines for the 2024 Southern Hemisphere Influenza Season.
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November 29-30, 2023: Public Workshop to Enhance Clinical Study Diversity to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups. Registration now open
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
Expiration date extension
Did you know? You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions.
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In case you missed it
Quick COVID-19 resources
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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. Also see, from HHS, Fact Sheet: End of the COVID-19 Public Health Emergency
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 450 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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