FDA News Release
FDA Roundup: February 25, 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:
- On Feb. 24, the FDA issued an update on our continuing efforts to understand and reduce exposure to PFAS from foods. The FDA made available new PFAS test results from our most recent survey of the general food supply that showed three samples—tilapia, cod, and shrimp, had detectable levels of at least one type of PFAS. Based on the best available current science, the FDA has no scientific evidence that the levels of PFAS found in the samples tested indicate a need to avoid any particular food. The FDA also posted on the Authorized Uses of PFAS in Food Contact Applications webpage, the first annual updates provided to the FDA from the three manufacturers that committed to the voluntary market phase-out of certain short-chain PFAS used in food packaging.
- On Feb. 24, the FDA revised the emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab) to change the dosing for the authorized use as pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric patients. Based on the most recent information and data available, Evusheld may be less active against certain Omicron subvariants. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose.
- On Feb. 24, the FDA updated the Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers page on FDA.gov to answer questions about SARS-CoV-2 antibody testing.
The update includes information about:
- Antibodies and Antibody Tests: The Basics
- Antibody Tests: Not for Use to Check Immunity
- Antibody Tests: Results and Terms
- On Feb. 24, the FDA added and updated the following question and answer resources: COVID-19: Test Development and Review and COVID-19 Test Uses.
- On Feb. 23, the FDA published a proposed rule to harmonize the Quality System (QS) regulation for medical devices with the international consensus standard for medical devices manufacturers - ISO 13485:2016. While the current QS regulation provides sufficient and effective requirements for the establishment and maintenance of a quality management system, regulatory expectations for a quality management system have evolved since the regulation was implemented over 20 years ago. The proposed rule will be open for public comments for 90 days at www.Regulations.gov under docket number (FDA-2021-N-0507) and on March 2, 2022, the FDA will hold a public advisory committee meeting to discuss the requirements and potential impacts of this proposed amendment to the agency’s regulations.
- On Feb. 22, the FDA approved the first generic of Farxiga (dapagliflozin) tablets, used to improve glycemic control in adults with type 2 diabetes mellitus. The most common adverse reactions associated with dapagliflozin are female genital mycotic (yeast) infections, nasopharyngitis (common cold), and urinary tract infections. One of FDA’s top priorities is to help bring more drug competition to the market to help address the high cost of medicines. FDA considers first generics to be important to public health and prioritizes review of submissions for these products to advance its goal of helping to provide access to affordable needed therapies for patients where no competition previously existed.
- On Feb. 22, as part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to My Natural Treatment for selling unapproved products with fraudulent COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
- COVID-19 testing updates:
- As of today, 419 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 289 molecular tests and sample collection devices, 85 antibody and other immune response tests and 45 antigen tests. There are 70 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 25 antigen tests and 10 molecular tests for serial screening programs. The FDA has also authorized 847 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