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BioPharmaceutical Approvals

FDA: Don’t Let GDUFA DMF Assessments Delay ANDAs

This article was originally published in The Gold Sheet

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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