FDA Action Alert: Possible COVID-19 Action and Mallinckrodt’s Terlipressin

It’s entirely possible that what we will be seeing most from the U.S. Food and Drug Administration (FDA) for the month of September is related to treatments and vaccines for COVID-19. In general, the vaccines probably will not have actionable data—if then—until mid-October, although it’s not impossible that there will be enough data on a few of the clinical trials, primarily Moderna, Pfizer and BioNTech, and AstraZeneca and the University of Oxford, to warrant some sort of Emergency Use Authorization (EUA). October or later, however, is more likely.