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The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
- The FDA issued a reminder to health care providers to give clear, step-by-step instructions to patients who, in a health care setting, self-collect anterior nasal samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an adequate sample for testing, which may decrease the sensitivity of the test.
- The FDA issued a safety communication to remind health care providers and the public that results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination. The FDA also updated the Serology/Antibody Tests: FAQs on Testing for SARS-CoV-2 and the Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers web pages to provide updated information on the use of SARS-CoV-2 antibody test results.
- The FDA updated the definition of high risk for COVID-19 to include additional medical conditions and factors associated with increased risk for progression to severe disease. This update applies to the emergency use authorizations (EUAs) for REGEN-COV (Casirivimab and Imdevimab) and Bamlanivimab and Etesevimab. More information is available in the fact sheets for each EUA:
- The FDA’s Clinical Methodologies Group within CDER’s Office of Medical Policy received a $9.2 million grant through the HHS Office of the Assistant Secretary for Planning and Evaluation’s (ASPE) Patient Centered Outcomes Research Trust Fund. The ASPE grant will fund expansion of the CURE ID platform to facilitate automated collection of de-identified data from electronic health records and clinical disease registries worldwide for COVID-19 and other difficult-to-treat infectious diseases.
- As part of the FDA’s effort to protect consumers, on May 19, 2021, the agency issued a warning letter jointly with the Federal Trade Commission to BGP, LLC for selling an unapproved product with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
- Testing updates:
- As of today, 376 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 272 molecular tests and sample collection devices, 79 antibody and other immune response tests, and 25 antigen tests. There are 50 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, four antigen over-the-counter (OTC) at-home tests, and two molecular OTC at-home tests.
- The FDA has authorized nine antigen tests and four molecular tests for serial screening programs. The FDA has also authorized 508 revisions to EUA authorizations.
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