U.S. FDA Drug Master File Requirements
A drug master file is a submission of information to the U.S. Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigational new drug application under part 312 or submits an application or an abbreviated application or an amendment or supplement to them under this part, or to permit the holder to authorize other persons to rely on the information to support a submission to U.S. FDA without the holder having to disclose the information to the person.
Registrar Corp assists companies with the following DMF requirements:
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- File a new DMF with U.S. FDA with U.S. FDA
- Update or Amend an existing DMF with U.S. FDA with U.S. FDA
- Appoint Registrar Corp as your Agent for U.S. FDA Communications
- File and Annual Report with U.S. FDA
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If you already have a DMF number with U.S. FDA
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| Option 1: Update your existing DMF with U.S. FDA
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Click the Update button below for any of the following:
- 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 ››
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Option 2: Order a Certificate of Filing issued by Registrar Corp for your existing DMF
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Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their DMF filing. A Certificate of Filing issued by Registrar Corp serves to verify your DMF.
Order a DMF Certificate ››
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U.S. FDA Regulations:
U.S. FDA DMF Regulation: 21 C.F.R. Section 314.420
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| 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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