![]() This guideline is intended to provide DMF holders with procedures acceptable to the agency for preparing and submitting a DMF. Different approaches may be followed, but the applicant is encouraged to discuss significant variations in advance with FDA reviewers to preclude spending time and effort in preparing a submission that FDA may later determine to be unacceptable.ĭrug Master Files are provided for in 21 CFR 314.420. It does, however, offer guidance on acceptable approaches to meeting regulatory requirements. ![]() This guideline does not impose mandatory requirements (21 CFR 10.90(b)). Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these.Ī DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. A DMF is submitted solely at the discretion of the holder. The submission of a DMF is not required by law or FDA regulation. INTRODUCTIONĪ Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Listing of Persons Authorized To Refer to a Drug Master FileĮ. Notice Required for Changes to a Drug Master Fileī. Policies Related to Processing Drug Master Filesī. Copy to Applicant, Sponsor, or Other Holder VI. AUTHORIZATION TO REFER TO A DRUG MASTER FILEī. Type V: FDA Accepted Reference Information 2. Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their PreparationĮ. Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Productĭ. Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnelī. ![]()
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