- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Monday, the FDA released new updates detailing the agency’s Cyclospora prevention and research efforts. Cyclospora cayetanensis (C. cayetanensis) is a parasite that causes the foodborne intestinal illness cyclosporiasis. People can become infected with cyclosporiasis by ingesting food or water that’s contaminated with C. cayetanensis. The most common symptoms of cyclosporiasis are diarrhea, weight loss, nausea, and fatigue.
- The FDA announced it will present a webinar for stakeholders on Aug. 11, 2022, at 1 p.m. EST, to discuss Food Facility Registration, Biennial Renewal, and how to obtain an acceptable Unique Facility Identifier. U.S. and foreign human and animal food facilities that are required to register with the FDA must renew their registration this year between Oct. 1 and Dec. 31, 2022.
- On Friday, the FDA announced it is developing a food safety prevention strategy to enhance the safety of fresh and frozen berries. The strategy is being developed in response to a history of hepatitis A (HAV) and norovirus (NoV) outbreaks linked to the consumption of both fresh and frozen berries.
- When the FDA first issued the Emergency Use Authorization (EUA) authorizing Paxlovid, it established a 12-month product shelf-life. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. The FDA has authorized extended expiration dates for these lots to reflect the 12-month product shelf-life, when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 105 for Paxlovid.
- 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 28 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1046 revisions to EUA authorizations
- The FDA has authorized 28 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1046 revisions to EUA authorizations
- 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.
Related Information
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Boilerplate
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.
