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

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

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