Letter updating a file

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TYPES OF DMFs The types of DMFs are: Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable) Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product Type III Packaging Material Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation Type V FDA Accepted Reference Information STATUS OF DMFS “A” = Active.

[Old content structure of DMFs - see e CTD for currently accepted internationally recognized structure/format] A. Drug Substance Type II DMFs for drug substances may be submitted in the format for "Drug substance" in the "Guidance for Industry M4Q: The CTD - Quality".(Category 3) Drug Substance: See the current Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances.

Companies may convert an existing DMF in non-CTD format to CTD format. Information common to different products—e.g., analytical procedures—can be accessed by reference (or links in the case of an Electronic DMF) from the relevant section for that product, e.g., 3.2.4.2 [Flavor 1].

(See Requesting a Pre-Assigned Application number.) Companies submit DMFs following the format recommended in the Guidance for Industry M4Q: The CTD - Quality.

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Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. b) Specification and routine tests of the Raw Materials. An Agent Appointment Letter is NOT an LOA and should not be called “Letter of Authorization” and should not be submitted in Section 1.4.1 1.4.2 - Statement of Right of Reference Submission by recipient of a Letter of Authorization with a copy of the LOA and statement of right of reference.

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“I” = Inactive “N” = Not an assigned number “P” = DMF Pending Filing Review The status conveys no information about whether DMF has been reviewed for technical content.

This means that the DMF was found acceptable for filing, administratively, and is up-to-date.

The address for submitting DMF documentation to the FDA in the Guidance is [email protected] DMF guidance recommendations, in general, still apply.

For drug master files, the version posted on the web is the current version.

DMF LISTS IMPORTANT NOTE The current list contains DMFs RECEIVED by March 31, 2012. The list of DMFs is current as of March 31, 2012, through DMF 25923.