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The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
- October 13, 2023: FDA Roundup including the list of guidance documents it intends to publish Fiscal Year 2024.
- October 06, 2023: FDA Roundup including an update on the recalled Philips ventilators, BiPAP machines, and CPAP machines associated with the breakdown of PE-PUR foam.
- October 03, 2023: FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants.
- October 03, 2023: FDA Roundup including the announcement of a public workshop “Defining ‘Candy-Like’ Nonprescription Drug Products” in partnership with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).
- September 29, 2023: FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies.
- September 26, 2023: FDA Roundup including the announced it has awarded 10 new clinical trial studies, funded by Congress through the Orphan Products Grants Program, to support the development of medical products for rare diseases.
- September 26, 2023: FDA Roundup including final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
- September 22, 2023: FDA Roundup including revised, draft guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.
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Updated mRNA COVID-19 Vaccines
- On October 03, 2023, FDA amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula. Individuals 12 years of age and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to receive one dose and unvaccinated individuals receive two doses.
- The updated vaccine addresses currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. Consistent with the totality of the evidence and input from the FDA’s expert advisors, the Novavax COVID-19 Vaccine, Adjuvanted, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5 (2023-2024 formula).
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Related Information
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COVID-19 Tests Granted Marketing Authorization
FDA Proposes Rule About Laboratory Developed Tests
- On September 29, 2023, FDA announced a proposed rule: Medical Devices; Laboratory Tests.
- The proposed rule seeks to amend the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.
- Along with this amendment, the FDA is proposing a policy under which the FDA intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach to LDTs.
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Note: This proposed rule is not for implementation at this time.
- Submit comments under docket number FDA-2023-N-2177 at www.regulations.gov between October 2, 2023 and December 1, 2023 to ensure the FDA considers comments on this proposed rule before it begins work on the final version of the rule.
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FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies
- On September 29, 2023, FDA announced the opportunity for a limited number of sponsors to participate in a pilot program allowing for more frequent communication with FDA staff to provide a mechanism for addressing clinical development issues.
- Selected participants of the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program will be able to obtain frequent advice and regular ad-hoc communication with FDA staff to address product-specific development issues, including, but not limited to, clinical study design, choice of control group and fine-tuning the choice of patient population.
- The program will be open to sponsors of products currently in clinical trials under an active Investigational New Drug application (IND), regulated by the Center for Biologics Evaluation and Research (CBER) and/or the Center for Drug Evaluation and Research (CDER). Eligibility criteria for the pilot differs between CBER and CDER-regulated products.
- More information on the program’s eligibility requirements can be found in the Federal Register Notice.
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Emergency Use Authorization (EUA) updates
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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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FDA Medical Countermeasures Initiative (MCMi) News)
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