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
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