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FDA Roundup: June 21, 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  • Today, the FDA issued the draft guidance, Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures. The FDA’s recommendations are intended to help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems, or “tissue containment systems.” Comments should be submitted at www.regulations.gov under docket number FDA-2022-D-0737 within 60 days to ensure that the FDA considers comments before it begins work on the final version of the guidance. Additional information is available at Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures | FDA
  • Today, the FDA approved a second generic naloxone hydrochloride (HCI) intranasal spray. Naloxone HCI is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose.  
  • Today, the FDA issued the final guidance, FDA Oversight of Food Covered by Systems Recognition Arrangements: Guidance for Food and Drug Administration Staff. The document provides guidance related to the agency’s regulatory oversight activities for foods covered by a Systems Recognition Arrangement between the FDA and another country’s food safety authority, in which the agencies have determined through an assessment that they operate comparable regulatory programs that produce similar food safety outcomes. 
  • COVID-19 testing updates: 
    • As of today, 438 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 303 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 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, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1005 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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