Drug Master File (DMF) Submission Resources

The draft guidance for industry Drug Master Files describes how to prepare and submit DMFs. Here are some additional resources:

• Requesting a Pre-Assigned Application Number: To be included in DMF submissions to CDER.
  • To request a pre-assigned number for CBER submissions, send a secure email to cberrims@fda.hhs.gov that includes the sponsor/applicant name and address, point of contact name and number, product name, and anticipated submission date.
• Electronic Common Technical Document (eCTD) Website: eCTD is CDER’s standard format for electronic regulatory submission, including DMFs.
• Electronic Submissions Gateway: Central transmission point for sending information electronically to FDA.
• Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Rev. 6): Guidance for industry that describes how sponsors and applicants must organize content that they submit electronically to FDA. Revision 7 of this guidance has been issued as a draft for public comment and, when final, will represent FDA’s current thinking on this topic.
• Comprehensive Table of Contents Headings and Hierarchy: Complete list of CTD section headings.
• FDA IND, NDA, ANDA, or Drug Master File Binders: Information about binders that can be used for certain submissions.
• FDA Form 3938: A standardized fillable electronic form for DMF submissions
  • Instructions for filling out FDA Form 3938
• Quick Guide to Creating a Structure-Data File (SD File) for DMF Submissions