The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
- The FDA added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance clarifies two previously suggested methods for obtaining informed consent from a hospitalized patient in isolation. In addition, the guidance includes a new question-and-answer regarding how to obtain informed consent from a prospective trial participant in certain circumstances where the enrollment timeframe is limited and the patient can receive a copy of an informed consent document electronically but cannot sign it electronically or print it out for signature. The guidance also clarifies recommendations on documenting details when using video conferencing for trial visits.
- The FDA issued an emergency use authorization (EUA) for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of COVID-19 by their healthcare provider to the Centers for Disease Control and Prevention (CDC). The FDA has previously issued EUAs to BioFire Diagnostics, LLC and QIAGEN GmbH for their tests, which include many other respiratory organisms in addition to the viruses that cause flu and COVID-19. These combination tests work by testing a single sample from a patient for multiple respiratory diseases. Tests based on taking just one sample from a patient may help alleviate the need for multiple sample collections, which means less discomfort for the patient with faster and more comprehensive results. The FDA encourages additional developers to work with the FDA on combination tests that may be useful in preserving critical testing resources during the upcoming flu season.
- On July 2, 2020, the U.S. Food and Drug Administration (FDA) issued the second Emergency Use Authorization (EUA) for a COVID-19 antigen test. An antigen test is a diagnostic test that quickly detects fragments of proteins found on or within the virus by testing samples collected from the patient’s nasal cavity using swabs. The EUA was issued to Becton, Dickinson and Company (BD) for the BD Veritor System For Rapid Detection of SARS-CoV-2. Antigen tests can provide results in minutes, be produced at a lower cost than molecular tests, and potentially scale to test millions of Americans per day once multiple manufacturers enter the market. However, antigen tests may not detect all active infections, as they do not work the same way as a PCR test. The FDA will continue to support the development, review, and monitoring of tests to help ensure accuracy while balancing the urgent need for these critical diagnostics.
- Testing updates:
- To date, the FDA has currently authorized 164 tests under EUAs; these include 137 molecular tests, 25 antibody tests, and 2 antigen tests.
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