FDA: Completeness Assessments for Type II API DMFs Under GDUFA

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 DMF holders are required to pay a DMF fee when first authorizing the reference of their DMF in a generic application, Type II API DMFs must undergo an FDA completeness assessment (CA).