The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA issued an Emergency Use Authorization (EUA) in response to concerns relating to insufficient supply and availability of gowns and other apparel, such as operating-room shoe covers, for use by health care personnel as personal protective equipment (PPE) for use in health care settings in accordance with Centers for Disease Control and Prevention recommendations to protect both health care personnel and patients from the transfer of SARS-CoV-2, the virus that causes COVID-19, in low or minimal risk level situations to prevent the spread of COVID-19.
- The FDA provided flexibility to farms regarding eligibility for the qualified exemption under the Produce Safety Rule during the COVID-19 public health emergency. Farms that are currently eligible for the qualified exemption and associated modified requirements will still be considered eligible, even if they shift sales away from qualified end-users, so long as they continue to meet the requirement that their average food sales during the previous three years total less than $500,000 (adjusted for inflation).
- The FDA approved an abbreviated new drug application (ANDA) for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
- Testing updates:
- During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
- To date, the FDA has authorized 113 tests under EUAs, which include 100 molecular tests, 12 antibody tests, and 1 antigen test.