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# GDUFA Completeness Assessments Guidance
- URL: https://www.fdaweb.com/gdufa-completeness-assessments-guidance/
- Published: 2016-02-16T12:00:00.000Z
- Updated: 2026-09-15T02:36:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134768

> FDA has issued a guidance, *Completeness Assessments for Type II API D MFs Under GDUFA*, to make suggestions about information to be included in a drug master file (DMF) to facilitate a GDUFA completeness assessment. The [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM321884.pdf?ref=fdaweb.com) says it is intended for holders of Type 2 active pharmaceutical ingredient (API) DMFs that are or will be referenced in an ANDA, an amendment to an ANDA, a prior approval supplement to an ANDA, or an amendment to such a supplement.  
>  
> Under GDUFA, DMF holders are required to pay a DMF fee when first authorizing the reference of their DMF in a generic application. Also, Type 2 API DMFs must undergo an agency completeness assessment.  
>  
> The guidance does not apply to Type 2 API DMFs used to support NDAs, BLAs, other submissions that are not generic submissions, or any other types of DMFs.  
>  
> The document includes an introduction and background information, completeness assessment, completeness assessment outcomes, and API information included in a generic drug submission.