FDA Guidance for the Industry
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)
The guidance makes recommendations about the information that should be included in the DMF to facilitate a GDUFA CA. The guidance does not apply to Type II API DMFs used to support new drug applications (NDAs), biologics license applications (BLAs), other submissions that are not generic drug submissions, or any other types of DMFs.
Download FDA Guidance in PDF
Last Updated: 2016-06-17