The Food and Drug Administration (FDA) proposes to amend the sterility test requirements for biological products. This proposed rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products.
ISPE will be collecting comments for the proposed amendments from interested members. Please submit comments to firstname.lastname@example.org by 25 August 2011.
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