FDA Guidance for Industry: Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

Title:
FDA Guidance for Industry: Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

https://www.gmp-compliance.org/files/guidemgr/48754313_GDUFAIII_Gui_DMF_Early_Review.pdf

Origin/Publisher:

FDA

Content:
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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