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Botanical Review Team Develops “Post-CMC” Approach

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s Botanical Review Team has identified new ways to help assure the quality of complex natural mixtures. While not specified in the agency’s 2004 guidance on botanical drugs, the team is adding its “post-CMC” approach to conventional CMC analyses and “pre-CMC” agricultural oversight.


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