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FDA: Don’t Let GDUFA DMF Assessments Delay ANDAs

This article was originally published in The Gold Sheet

Executive Summary

Generics manufacturers and their active substance suppliers should take steps to protect ANDAs from delays that new user fee requirements could cause, FDA official says. FDA’s new drug master file (DMF) review team will play a key role in keeping the new DMF completeness assessments from delaying ANDA filings.

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