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FDA Roundup: September 30, 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 Continues Important Work on Substance Use and Overdose Prevention Efforts,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. The National Academies for Science, Engineering, and Medicine (NASEM) report “Pain Management and the Opioid Epidemic,” contained recommendations for the FDA’s consideration, as well as broader recommendations for federal agencies, state and local governments, and health-related organizations. As we continue to prioritize our substance use and overdose prevention efforts, the NASEM report has been and will remain an important source to consider in our decision making.
  • Today, the FDA published a Constituent Update to remind owners, operators, or agents in charge of a domestic or foreign food facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S, to register the facility with FDA or to renew their FDA registration between October 1 and December 31, 2022. 
  • On Thursday, the FDA approved SpectoGard, the first generic spectinomycin sulfate injectable solution for the treatment of bovine respiratory disease (pneumonia). SpectoGard contains the same active ingredient (spectinomycin sulfate) in the same concentration and dosage form as the approved brand name drug product, Adspec, which was first approved in January 1998. SpectoGard is only available by prescription because a veterinarian’s expertise is required to determine if SpectoGard is an appropriate treatment for cattle. SpectoGard is sponsored by Bimeda Animal Health Ltd.
  • On Wednesday, the FDA issued a warning letter jointly with the Federal Trade Commission to Bespoke Apothecary LLC for selling unapproved and misbranded COVID kit and Post Virus Recovery Herbal Tea products as drugs for use in treating or preventing COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
  • On Wednesday, the FDA approved Simplera Otic Solution, the first generic animal drug product that has single dose treatment with a 30-day duration of effect for otitis externa (outer ear infection) in dogs. Simplera Otic Solution is a prescription product that contains the same active ingredients in the same concentration and dosage form as the approved brand name drug product, Claro, which FDA first approved in September 2015. Simplera is sponsored by Vetoquinol USA, Inc.
  • On Tuesday, the FDA announced updates to its COVID-19 test policy to address public health testing needs during this phase of the COVID-19 public health emergency. Over the last two years more than 400 COVID-19 tests have been granted emergency use authorization and there are generally enough at-home tests, tests that can be used at the point-of-care such as health clinics, and laboratory-based tests to meet testing needs. The FDA is revising its COVID-19 test policy to encourage most COVID-19 test developers to pursue a traditional premarket review pathway for their tests, rather than emergency use authorization. The FDA intends to prioritize its review of emergency use authorization requests on COVID-19 diagnostic tests that are likely to have a significant public health benefit or are likely to fulfill an unmet need. This could include novel technologies like the use of breath samples, or unique features like the ability of a test to detect a new SARS-CoV-2 virus variant. The FDA actions include: 
  • COVID-19 testing updates:
    • As of today, 437 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 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 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1124 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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