Drug Master File (DMF) Submissions on New FDA Form 3938
January 13, 2021
- January 13, 2021
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How will eCTD format requirements and Form 3938 change your drug master file (DMF) submissions?
The new electronic Form 3938 will provide a standardized fillable electronic form to accompany all new DMF submissions, DMF amendments and annual reports. Form 3938 will not only standardize the required material but will capture all relevant DMF submission information in the eCTD format and allow for the automated pull of DMF information into FDA databases.
Subject matter experts from the agency will walk participants through a mock form completion and address FAQs to ensure a thorough understanding of both the purpose and utility of the new Form 3938.
- Acquire a more robust understanding of how this new form intersects with the current requirement for Type II, Type IV and Type V DMFs to be submitted in electronic format.
- Understand how the various sections of the new Form 3938 interact with one another (for example: if check “A” then the following options are available).
- Get a first look at the new Form 3938 and its interactive and fillable format.
- DMF Holders
- Responsible Officials at DMF Holder Companies
- U.S. Agents of DMF Holders
- Drug product excipient suppliers
- Drug substance and active pharmaceutical ingredient (API) suppliers
- Drug product container and closure suppliers
- Drug product manufacturers
CDR David Skanchy
Division of Lifecycle API | Office of New Drug Products | Office of Pharmaceutical Quality | CDER
Technical Information Specialist
Division of Lifecycle API | Office of New Drug Products (ONDP)| OPQ | CDER
FDA Drug Master File (DMF) Website
Pre-assigned DMF Number Request
|Form 3938 Webinar PDF||pdf (1.29 MB)|