Articles by Angie Drakulich - Pharmaceutical Technology

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FDA Issues Draft Guidance on CMC Postapproval Changes for Annual Reports

Jul 1, 2010
By: Angie Drakulich

The US Food and Drug Administration issued on June 25 a draft guidance for industry, "CMC Postapproval Manufacturing Changes Reportable in Annual Reports," to provide recommendations to drug applicants about the types of changes that may be included in annual reports.

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