Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They:
Allow parties to reference material without disclosing DMF contents to those parties.
Are not required by statute or regulation.
Are neither approved nor disapproved. Instead, FDA reviews the technical contents of DMFs in connection with the review of applications that reference them (e.g., NDAs, ANDAs, INDs, BLAs).
See the draft guidance for industry Drug Master Files for detailed information about preparing and submitting DMFs and to learn about FDA’s DMF review process. (When final, this guidance will represent FDA’s current thinking on DMFs.)
The following DMF web pages cover additional information about DMFs and their submission:
List of DMFs
Types of DMFs
Submission Resources
Templates
Related Information
Frequently Asked Questions (FAQs) (coming soon)
Contact Information
Please contact [email protected] with all DMF-related submission questions. Include the DMF number, if applicable.
Source form FDA
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