- 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 a safety communication warning people not to use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging. The test has not been authorized, cleared or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test.
- Today, the FDA issued a safety communication warning people not to use the SD Biosensor STANDARD Q COVID-19 Ag Home Test. This test is packaged in a white and magenta box and has not been authorized, cleared or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test.
- Today, the FDA issued a safety communication warning people not to use the ACON Laboratories “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).” This test is packaged in a dark blue box and has not been authorized, cleared or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test.
- On Feb. 28 the FDA posted a new Consumer Update, Infant Formula Recall: What to Know, reminding consumers not to use the recalled powdered infant formulas (Similac, Alimentum, EleCare, and one lot of Similac PM 60/40) produced at the Abbott Nutrition facilities in Sturgis, Michigan. The Consumer Update is based on the latest FDA Advisory, FDA Investigation of Cronobacter and Salmonella Complaints: Powdered Infant Formula (February 2022).
- On Feb. 28, the FDA published the FDA Voices, “Sharing Experiences in Rare Diseases Together,” bylined by Janet Woodcock, M.D., Principal Deputy Commissioner, and Sandra Retzky, D.O., J.D., M.P.H., director of the FDA’s Office of Orphan Products Development. This year, the FDA is part of the worldwide community observing Rare Disease Week—Feb. 28-March 4, including hosting FDA’s Rare Disease Day on March 4. The theme is: “Sharing Experiences in Rare Diseases Together.”
- On Feb. 28, the FDA announced the availability of “Responsible and Prudent Use of Anthelmintic Chemicals to Help Control Anthelmintic Resistance in Grazing Livestock Species,” a resource drafted in part by FDA experts and published by the World Organisation for Animal Health, an independent global organization dedicated to promoting and protecting animal health.
- COVID-19 testing updates:
- As of today, 420 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 85 antibody and other immune response tests and 45 antigen tests. There are 70 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, 14 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 25 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 850 revisions to EUA authorizations.
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.
- FDA Office of Media Affairs