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  5. FDA Roundup: August 30, 2022
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FDA News Release

FDA Roundup: August 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’s Overdose Prevention Framework Aims to Prevent Drug Overdoses and Reduce Death,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. The priorities within the framework are: (1) supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; (2) encouraging harm reduction through innovation and education; (3) advancing development of evidence-based treatments for substance use disorders; and (4) protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.
  • Today, the FDA’s Center for Veterinary Medicine (CVM) announced that registration is now open for a virtual public listening session on the agency’s regulation of animal foods with certain types of claims such as environmental benefit claims (e.g., reduced greenhouse emissions), production claims (e.g., growth promotion, feed efficiency) and claims about effects on the animal microbiome. The FDA is seeking public comments on how its existing policy, CVM Policy and Procedures Manual (PPM) 1240.3605, Regulating Animal Foods with Drug Claims, could be updated to reflect evolving scientific knowledge and promote innovation. The listening session will take place on October 18, 2022. For more information and to register to attend and/or present at the event, please visit: FDA Virtual Listening Session on the Regulation of Animal Foods with Certain Types of Claims.
  • Yesterday, the FDA issued a safety communication to alert patients, caregivers and health care providers that Philips Respironics recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals of concern, and it may also cause the machine to fail. This recall is not associated with the PE-PUR foam issue for certain BiPAP machines recalled in June 2021. However, this recall does apply to some of the devices that were recalled in June 2021.
  • On Friday, the FDA issued marketing authorization for the Vibrant System, a first-of-a-kind device that is an orally administered, vibrating capsule intended for treating chronic idiopathic constipation in those who have not experienced relief by using available laxative therapies for at least a month. The system is made up of a single-use capsule and a pod, which controls the activation of the capsule.
  • COVID-19 testing updates:
    • As of today, 439 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 78 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 1101 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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