Description
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:
Scope & Applicability
Product Classes
2Guidance intended for holders of Type II API drug master files
Subject of the GDUFA completeness assessment checklist
Stakeholders
2new facilities added by the DMF holder
Assists FDA in communications with foreign establishments
Regulatory Context
Attributes
5User fee required under GDUFA for Type II API DMFs
Stability Summary and Conclusions
levels of existing and new impurities; Characteristic of drug substance that may change with starting material redesignation; A comparison of the impurity profile of pre- and post-modification material to establish equivalence; Evaluation of the impurity profile for intermediates or drug substance; Potential to adversely affect drug substance quality; A description of the identified and unidentified impurities present in a drug substance.; The description of identified and unidentified impuritie
A DMF for which the FDA has made a determination that it was acceptable for filing
The required electronic format for DMF submissions.
Identified Hazards
Hazards
2Bovine/Transmissible spongiform encephalopathy certification required for animal-sourced materials
Potential genotoxic impurities summarized in a table
Related CFR Sections (3)
- 21CFR314.420§ 314.420 Drug master files.
(a) A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigationalRead full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →
See Also (8)
- Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry (Status: Final)
- Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry (Status: Draft)
- Good ANDA Submission Practices Guidance for Industry (Status: Final)
- Postapproval Changes to Drug Substances Guidance for Industry (Status: Draft)
- Codevelopment of Two or More New Investigational Drugs for Use in Combination (Status: Final)
- Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry (Status: Final)
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2 (Status: Final)
- ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry (Status: Draft)