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US FDA Clarifies Expectations For Completeness Assessments For Drug Master Files

The US Food and Drug Administration has clarified what it expects to see in drug master file (DMF) completeness assessments for active pharmaceutical ingredients (APIs)1.

The US Food and Drug Administration has clarified what it expects to see in drug master file (DMF) completeness assessments for active pharmaceutical ingredients (APIs)1.

FDA's expectations for completeness assessments were outlined in final guidance issued in February 2016. The pharmaceutical industry had complained that the draft guidance on the matter that was issued in...

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