FDA Details Shelf-Life Testing For Generic Drugs

Law360, New York (August 26, 2013, 5:47 PM EDT) -- The U.S. Food and Drug Administration on Monday told generic-drug makers how it expects them to determine a product's shelf life, discussing sample sizes and study duration in elaborating on recently issued guidance.

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...
To view the full article, register now.