- For immediate release:
The United States Food and Drug Administration today announced the following actions taken as part of its ongoing response efforts to the COVID-19 pandemic:
- On Monday, the U.S. District Court for the District of New Jersey issued a permanent consent injunction order prohibiting a New Jersey-based business from receiving or distributing drugs until the business complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements. The lawsuit, filed by the Department of Justice on behalf of the FDA, alleged that the Natural Solutions Foundation, an organization, and its two directors, Rima Laibow and Ralph Fucetola, violated FD&C law by selling unapproved and mislabeled drugs. intended to cure, mitigate, treat or prevent COVID-19. Defendants are used to making unproven claims about their nanosilver product. Greg Noonan, acting deputy director of the FDA for the office of dietary supplement programs, provided a quote to the Department of Justice.
- Today, the FDA updated the Emergency Use Clearance (EUA) for COVID-19 convalescent plasma. The update limits the authorization to the use of convalescent COVID-19 plasma with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive therapy. These patients can be treated on an outpatient basis or in hospital. Additionally, to help ensure the manufacture of high titer COVID-19 convalescent plasma, the EUA reviews revise the acceptable tests and increase the thresholds of allowable results to be used for the manufacture of COVID-19 convalescent plasma with titers. high anti-SARS-CoV-2 antibodies.
- Today, the FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests webpage to share new information regarding the impact of the omicron variant of SARS-CoV-2 on testing for diagnosis of antigens. The update includes the results of preliminary studies of some antigen tests using patient samples containing live virus. Early data suggests that antigen tests detect the omicron variant but may have reduced sensitivity. The FDA will continue to work with the National Institutes of Health (NIH) RADx program to further evaluate the performance of antigen tests using patient samples containing live virus.
- Testing updates:
- To date, 419 tests and specimen collection devices have been approved by the FDA under Emergency Use Authorizations (EUA). These include 290 molecular tests and specimen collection devices, 87 antibody tests and other immune response tests, and 42 antigen tests. There are 67 molecular clearances and one antibody clearance that can be used with home samples. There is one EUA for home molecular prescription testing, three EUAs for home antigen prescription testing, 12 EUAs for home over-the-counter (OTC) antigen testing, and three EUAs for OTC molecular testing. home.
- The FDA has authorized 23 antigen tests and nine molecular tests for serial screening programs. The FDA has also cleared 747 reviews of EUA authorizations.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.