CDER SBIA Chronicles - DMF 101

CDER SBIA Chronicles: DMF 101

The topic of this month’s issue of the FDA/CDER Small Business Chronicles is titled “DMF 101” and serves as an introduction to the Drug Master File (DMF). It is possible for a firm submitting an application to FDA to incorporate confidential information submitted by another firm. This is done via a DMF. The DMF is a submission to the 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. DMFs are generally created to allow a party other than the DMF holder to reference material without disclosing to that party the contents of the file.  

There are four types of DMFs that correspond to the type of information being submitted (Note that Type I DMFs - Manufacturing Site, Facilities, Operating Procedures, and Personnel - were eliminated in 2000 and are no longer applicable):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

A company may submit a DMF to FDA to support various applications, such as 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. There is no requirement for a company to submit a DMF to FDA. FDA ordinarily does not review DMFs independently of an application that references the DMF. DMFs are neither approved nor disapproved. Rather, the agency will review information in a DMF only when an IND sponsor, an applicant for an NDA, ANDA, or Export Application, or another DMF holder incorporates material in the DMF by reference. If FDA reviewers find deficiencies in the information provided in a DMF, a letter describing the deficiencies is sent to the DMF holder. FDA will notify the person who relies on the information in the deficient DMF that additional information is needed in the supporting DMF.

To keep reading, please find the rest of the newsletter at DMF 101.

Our previous newsletters are archived on our webpage at: http://www.fda.gov/cdersmallbusinesschronicles.

Enjoy!

The CDER Small Business and Industry Assistance Team  

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The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

• Email: CDERSBIA@fda.hhs.gov
• Phone: 1-866-405-5367
• Phone: (301) 796-6707
• Website: http://www.fda.gov/cdersbia