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Agency official urges use of FDA Form 3,938 to speed DMF reviews
Summary
An FDA presenter said including FDA Form 3,938 with Type 2 Drug Master File (DMF) submissions helps assessors locate administrative details, facility lists and referenced DMFs, which expedites review and reduces back-and-forth.
Agency official told attendees that submitting FDA Form 3,938 with a Type 2 Drug Master File makes it easier for assessors to find administrative information and related materials. The presenter said this fillable form "is used for all Drug Master File submissions" and showed how section fields (contacts, facilities, referenced DMFs) direct reviewers to the right documents.
The speaker stressed accuracy on the form and urged applicants and DMF holders to "please assure that all of the DMF numbers are accurate" to avoid delays. She recommended using section 9 of Form 3,938 to list facility functions and section 10 to flag secondary DMFs so reviewers can identify necessary assessments early in the review cycle.
