FDA News Release
FDA Roundup: February 15, 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 released a request for public comments about antimicrobial use in companion animals (e.g., cats, dogs, horses) and the potential impact of this use on antimicrobial resistance in both animals and people. The Federal Register notice includes specific questions for commenters to consider. The FDA intends to use the information collected to help develop strategies to further promote antimicrobial stewardship in companion animals.
- On Feb. 14, the FDA published the FDA Voices, “Innovation and Scientific Collaboration Moved the Generic Drug Program Forward In 2021,” bylined by Sally Choe, Ph.D., director of the Office of Generic Drugs in the Center for Drug Evaluation and Research. Highlighting a successful and productive year for generic drugs at the agency, the article captures key achievements for the program and also links to the new Office of Generic Drugs 2021 Annual Report.
- On Feb. 14, the FDA provided updates on interim results from two postmarket studies on Essure. The FDA remains committed to providing updates on the safety profile of Essure, a permanently implanted birth control device for women. Although Essure has not been available for implantation in the United States since December 2019, the FDA continues to monitor the product’s safety through an FDA-required postmarket surveillance study and other activities. Read more here.
- On Feb. 3, as part of the FDA’s effort to protect consumers, the agency issued a warning letter to the operator of one website, www.pharmacy2home.com, for offering for sale in the U.S. unapproved drugs for multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. Consumers can visit BeSafeRx to learn about how to safely buy medicine online. Consumers concerned about COVID-19 should consult with their health care provider.
- COVID-19 testing updates:
- As of today, 421 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 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, 15 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 26 antigen tests and 10 molecular tests for serial screening programs. The FDA has also authorized 826 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