Review of Drug Master Files (DMF) in Advance of Certain ANDA Submissions Under GDUFA

3 October 2022 — FDA published the draft guidance on Type II API DMFs under GDUFA for industry.

This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be referenced in an abbreviated new drug application (ANDA), or a prior approval supplement (PAS) to an ANDA.

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