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FDA Roundup: October 14, 2022

For Immediate Release:

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

  • Today, the FDA published the FDA Voices: “FDA Seeks Feedback on Distributed and Point-of-Care Drug Manufacturing,” by Michael Kopcha, Ph.D., R.Ph., Director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, and Manuel Osorio, Ph.D., Senior Scientist, Immediate Office of the Director, Center for Biologics Evaluation and Research. The agency is interested in these technologies because they could potentially provide flexibility for drug manufacturers to enable rapid and localized response to changing demand and increase timely access to quality drugs for U.S. patients.  
  • On Thursday, the FDA published the FDA Voices: “FDA Releases New, Prevention Strategies to Enhance Food Safety,” by Mark Moorman, Ph.D., Director of the Office of Food Safety, and Stephen Hughes, M.S., Prevention Coordinator. The FDA has investigated more outbreaks and conducted more research to advance our scientific understanding of the pathogens that contaminate food — than any other time in history. We now know more than ever about the reoccurrence of contributing factors that can cause contamination of certain foods by specific disease-causing bacteria. The agency is compiling these learnings into a series of “Prevention Strategies to Enhance Food Safety” that identify and target specific patterns that have emerged with certain food-hazard pairings. The strategies contain recommendations to guide the work of preventing future foodborne illnesses. 
  • On Thursday, the FDA reminded people that getting vaccinated in the fall can lower your chances of getting the flu. Flu viruses typically spread in fall and winter, with activity peaking between December and February. 
  • On Wednesday, the FDA announced it will hold a public meeting on Oct. 26, 2022, to offer an opportunity for discussion on the proposed recommendations for the reauthorization of the Animal Generic Drug User Fee Act (AGDUFA), which gives the FDA the authority to collect user fees that provide funding to support the generic new animal drug review process. These resources support the FDA’s responsibility to ensure these drugs are safe and effective and to enhance the timeliness and predictability of application review for generic animal drugs needed by various animal populations. Reauthorization of this program includes an annual revenue of at least $25 million in user fees, supplementing budget authority funding, for the generic new animal drug program. The program expires on Sept. 30, 2023.
  • COVID-19 testing updates:
    • As of today, 436 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 299 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1130 revisions to EUA authorizations.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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