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Drug Master File reviews

Executive Summary

Chemwerth President Peter Werth suggests that FDA could save approximately three months review time for cross referenced NDAs and ANDAs by allowing an initial reviewer to annotate an acceptable finding on samples provided for a given process. The initial acceptable notation would allow subsequent FDA reviewers to avoid testing the same sample from the same facility referenced by other applications, Werth said. The same process, he said, could be applied to drug master files. Werth said that a proposal by the Generic Pharmaceutical Industry Association proposing a review process for drug master files would add an additional costly and bureaucratic level of review. Chemwerth, he said, currently has seven bulk drug substance applications on file with FDA.
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PS013058

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