Issue Date: October 11, 2017
Issued by: Center for Drug Evaluation and Research
Topic(s): User Fees, Chemistry, Manufacturing, and Controls (CMC), Generic Drugs, Pharmaceutical Quality
Status: Final
Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry: Guidance for Industry
This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions). The guidance explains that, as of October 1, 2012, under the Generic Drug User Fee Amendments of 2012, commonly referred to as GDUFA:
Download the Guidance Document
