FDA Broadens Veklury EUA

Last week, the Food and Drug Administration (FDA) broadened the scope of the existing emergency use authorization (EUA) for Veklury (remdesivir; Gilead Sciences Inc.).Veklury is now authorized for the treatment of all hospitalized adult and pediatric patients with...

FDA Issues EUA for Convalescent Plasma

On August 23, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for convalescent plasma for the treatment of COVID-19. Based on scientific evidence available, the FDA determined that it is reasonable to believe that COVID-19...

FDA News Briefs for July 28, 2020

These Food and Drug Administration (FDA) developments came in this week:FDA Reissues EUA for COVID-19 Diagnostic TestThe FDA has reissued the emergency use authorization (EUA) for the LabCorp COVID-19 RT-PCR Test to include two new indications for use: testing for...

FDA Updates on Hand Sanitizers

The Food and Drug Administration (FDA) is warning consumers and health care providers about hand sanitizers containing methanol. Methanol is a substance that can be toxic when absorbed through the skin or ingested, and can be life-threatening when ingested.The FDA has...