FDA Will Accept Partial Stability Data For Generic Drugs In Shortage

FDA on Wednesday (Sept. 8) told generic drug makers they can skip submitting some stability data when seeking approval for generic drugs that are in shortage or vulnerable to shortage, or if the generic drug could help address the COVID-19 pandemic. In a revised question-and-answer guidance, the agency also says generic drug makers can conduct bioequivalence studies using test generic products that expired due to disruptions caused by the COVID-19 pandemic. However, they should not use expired reference products. FDA’s...