FDA Proposes More Flexible BioProduct Sterility Testing
The Food and Drug Administration issued a proposed rule to amend the sterility test requirements for biological products, which is intended to provide manufacturers greater flexibility and to encourage use of the most appropriate and state-of-the-art test methods for assuring…
Sign up for a free preview to unlock the rest of this article
Export Compliance Daily combines U.S. export control news, foreign border import regulation and policy developments into a single daily information service that reliably informs its trade professional readers about important current issues affecting their operations.
the safety of biological products. The more flexible requirements would also address the challenges of novel products that may be introduced to the market in the future and potentially enhance sterility testing of currently approved products, among other things. Comments are due by September 19, 2011.