- For Immediate Release:
Today, the U.S. Food and Drug Administration took the following actions in our ongoing response effort to the COVID-19 pandemic:
- The FDA issued a safety alert for fecal microbiota transplantation (FMT) procedures. The FDA has issued a safety communication about the potential for transmission of the COVID-19 virus through FMT, a procedure that delivers human donor stool into the colon of a patient to treat c. difficile infection in patients that have not responded to standard therapies.
- The FDA also updated its FAQs on Diagnostic Testing for SARS-CoV-2 regarding specimen collection for COVID-19 testing. Based on available data, FDA believes that, for symptomatic patients, nasal swabs could be used that access just the front of the nose rather than the depth of the nasal cavity. This would provide COVID-19 testing that is more comfortable for patients, allows self-collection of specimens at collection sites, and that can be performed with a simpler and more readily available swab.
- The FDA Oncology Center of Excellence issued a message recognizing that patients with cancer, due to potentially being immunocompromised, are at greater risk of contracting COVID-19, and the Center is working to address critical needs of patients with cancer and their health care providers.
- Diagnostics update: In certain emergencies, the FDA can often quickly issue an emergency use authorization for diagnostic tests based on FDA’s rolling review of data and where the request meets certain criteria. In the COVID-19 pandemic, the FDA has worked with more than 160 test developers who have said they will be submitting applications to make tests that detect the virus. To date, 15 emergency use authorizations have been issued for nation-wide use, including two today. Under our laboratory developed test policy during COVID-19, the FDA has been notified by more than 65 laboratories.
“The FDA is doing everything we can to support patients, health care professionals, manufacturers of FDA-regulated products and the public during this pandemic,” said FDA Commissioner Stephen Hahn, M.D. “The FDA is working around the clock to monitor and mitigate emerging coronavirus issues through collaborative efforts with federal partners, international regulators and medical product developers and manufacturers to help advance response efforts to combat the COVID-19 outbreak.”
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.
- Stephanie Caccomo