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…
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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.