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Home U.S. FDA Drug Regulations › U.S. FDA Drug Master File (DMF)

U.S. FDA Drug Master File Requirements

Drug companies can submit a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) to provide confidential information about facilities, processes, or articles. The DMF holder can then authorize others to use the information in support of a submission to FDA without disclosing the information to anyone other than FDA.

FDA will require all DMF submissions to be in electronic common technical document (eCTD) format beginning May 5, 2017. Registrar Corp's Regulatory Specialists will:
Drug Master File Certificates Issued By Registrar Corp
  • File a new DMF with U.S. FDA in eCTD
  • Update or Amend an existing DMF with U.S. FDA
  • Convert existing DMFs to eCTD
  • Serve as your Agent for U.S. FDA Communications
  • Reactivate inactive DMFs with U.S. FDA and convert them to eCTD

If you would like to file a new DMF with U.S. FDA


File a new DMF with U.S. FDA  ››

If you already have a DMF with FDA
  
Option 1:   Convert your DMF to eCTD
Converting an existing DMF to eCTD format may accelerate FDA's NDA/ANDA review process. FDA NDA/ANDA reviewers will request a paper copy of the DMF for any information needed that is not in electronic format, thus delaying the review.

Convert my DMF to eCTD  ››

  
Option 2:   Update your existing DMF with U.S. FDA
Click the Update button below for any of the following:
  • Update or Amend your DMF with U.S. FDA
  • File an Annual Report with U.S. FDA
  • Reactivate a DMF with U.S. FDA
  • Deactivate a DMF with U.S. FDA
Update your DMF Information with U.S. FDA  ››



 
U.S. FDA Regulations:

U.S. FDA DMF Regulation: 21 C.F.R. Section 314.420














Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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