FDA Details Shelf-Life Testing For Generic Drugs

Law360, New York (August 26, 2013, 5:47 PM ET) -- 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.


Follow our exclusive coverage of the trial of the year:

Dewey Trial Day 48: The People Rest