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FDA Clarifies Expectations for Completeness Assessments for Drug Master Files

 
• By Joanne S. Eglovitch

FDA has clarified its requirements for DMF completeness acceptance following complaints that the draft guidance was too vague. FDA elaborates on what constitutes a single drug substance, single manufacturing process and starting materials.

FDA has clarified what it expects to see in drug master file (DMF) completeness assessments (CAs) for active pharmaceutical ingredients.

FDA’s expectations for CAs were outlined in final guidance issued in February 2016. The pharmaceutical industry had complained that the draft guidance, issued in October 2012, was too...

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