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  5. FDA Roundup: August 12, 2022
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FDA News Release

FDA Roundup: August 12, 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 posted a safety communication to provide information to blood establishments regarding monkeypox virus and blood donations. Worldwide, there have been no reports of transmission of monkeypox virus through blood transfusion and the risk of transfusion-transmission remains theoretical. The communication explains that existing safeguards for blood safety are likely to identify individuals who present to donate who are diagnosed with monkeypox virus or who are currently at the greatest risk for infection with monkeypox virus. Further, the FDA will continue to monitor cases of monkeypox in the U.S. and worldwide and the available information about potential risk of transfusion-transmitted monkeypox virus. The FDA will provide additional information as it becomes available.  
  • On Thursday, the FDA issued a safety communication advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test. If repeat testing is not performed after a negative result, an infection may be missed and people may unknowingly spread the SARS-CoV-2 virus to others, especially if they are not experiencing symptoms. The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms. 
  • “The FDA’s new recommendations for at-home COVID-19 antigen tests underscore the importance of repeat testing after a negative test result in order to increase the chances of detecting an infection. These recommendations are based on sound scientific evidence and a result of the FDA’s collaboration with government and academic partners to assess at-home COVID-19 antigen test performance and ensure public health remains a top priority, particularly as the school season approaches. Throughout the pandemic, we have continued to learn about COVID-19 and the impact of variants on the performance of diagnostic tests designed to detect the virus, and we are committed to keeping the public updated so they can make the most informed health care decisions.” – Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health
  • On Thursday, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-mutant NSCLC. For safety information on Enhertu, including the risks and associated adverse reactions, read the prescribing information. The FDA also approved Oncomine™ Dx Target Test (tissue) and Guardant360® CDx (plasma) as companion diagnostics for Enhertu. If no mutation is detected in a plasma specimen, the tumor tissue should be tested.
  • On Wednesday, the FDA issued final guidance for shell egg producers on how to comply with certain provisions in the final rule titled, "Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” (egg rule).
  • On Wednesday, the FDA made available its annual Pesticide Residue Monitoring Program Report for Fiscal Year 2020 (FY 2020), summarizing findings from the program’s monitoring of human and animal foods in FY 2020.
  • 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 1074 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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