FDA News Release
Coronavirus (COVID-19) Update: Daily Roundup August 31, 2020
- For Immediate Release:
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
- The FDA alerted health care facility risk managers, procurement staff, and health care providers that medical gowns sold by Laws of Motion PPE, including surgical gowns, have potential quality issues that affect the level of fluid barrier protection and should not be used as personal protective equipment at this time. The Letter to Health Care Providers includes information for reporting problems with the Laws of Motion PPE gowns, including surgical gowns.
- The FDA broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.
- Testing updates:
- To date, the FDA has currently authorized 230 tests under EUAs; these include 186 molecular tests, 40 antibody tests, and 4 antigen tests.
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.
- Chanapa Tantibanchachai