Scope & Applicability
Stakeholders
4SSR applicant
The party responsible for submitting cross-reference submissions and the LOA.
SSR applicants
Multiple applicants coordinating identical REMS-related documents.
DMF holder
new facilities added by the DMF holder
Applicant
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
1eCTD format
The required electronic format for DMF submissions.
Related CFR Sections (1)
- 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 →
See Also (4)
- Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry: Guidance for Industry (Status: Final)
- Good ANDA Submission Practices Guidance for Industry (Status: Final)
- Postapproval Changes to Drug Substances Guidance for Industry (Status: Draft)
- CVM GFI #57 Preparation and Submission of Veterinary Master Files (Status: Final)