FDA Details Shelf-Life Testing For Generic Drugs
In a Q-and-A format document, the FDA offered specifics based on inquiries it received regarding guidance issued last year and finalized in June regarding so-called stability testing.
A sizable portion of the 16-page Q-and-A concerned the size of batches that must be tested. The FDA clarified that three "pilot scale" batches or two...
Already a subscriber? Click here to login