- For immediate publication:
The United States Food and Drug Administration announced today the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA added content to the appendix of questions and answers in its guide titled “Conducting Clinical Trials of Medical Products During the COVID-19 Public Health Emergency.” The updated guide clarifies two previously suggested methods for obtaining informed consent from an isolated hospitalized patient. Additionally, the guide includes a new question and answer on how to obtain the informed consent of a potential trial participant in certain circumstances where the enrollment period is limited and the patient may receive a copy of an electronically informed consent document but cannot sign it. electronically or print it for signature. The guide also clarifies the recommendations on documenting details when using video conferencing for test visits.
- The FDA issued an Emergency Use Authorization (USA) for the third diagnostic test for the detection and differentiation of viruses that cause influenza 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 the US to BioFire Diagnostics, LLC and QIAGEN GmbH for testing, which includes many other respiratory organisms in addition to the viruses that cause influenza and COVID-19. These combination tests work by analyzing a single sample from a patient to detect multiple respiratory diseases. Testing based on taking only one sample from a patient can help alleviate the need for multiple sample collections, which means less hassle for the patient with faster and more complete results. The FDA encourages additional developers to work with the FDA on combination testing that may be useful in preserving critical testing resources during the upcoming flu season.
- On July 2, 2020, the United States Food and Drug Administration (FDA) issued the second Emergency Use Authorization (USA) for a COVID-19 antigen test. An antigen test is a diagnostic test that quickly detects protein fragments found in or within the virus by analyzing 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 testing can provide results in minutes, be produced at a lower cost than molecular testing, and potentially scale to evaluate 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 in the same way as a PCR test. The FDA will continue to support the development, review, and monitoring of tests to help ensure accuracy and balance the urgent need for these critical diagnoses.
- Testing for updates:
- To date, the FDA has currently authorized 164 tests under the US; These include 137 molecular tests, 25 antibody tests, and 2 antigen tests.
The FDA, an agency within the US Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and safety of medicines, vaccines, and other biological products for human use and medical devices for humans and vets. The agency is also responsible for the security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation from our country and for regulating tobacco products.
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