mdi Consultants
The FDA is notifying companies involved in research containing cannabis and cannabis-derived compounds of the benefits of using Drug Master Files (DMFs). These files are submissions to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. Companies are able to reference material without disclosing DMF content to those companies. Additionally, these files have no cost associated to their submission to the FDA in support of INDSs or NDAs. However, there is a provision for DMF fees if submitted in support of ANDAs in accordance with the Generic Drug User Fee Amendments (GDUFA).
To provide the FDA’s thoughts on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds, the agency published “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry” in July 2020. It is critical to the FDA to continue to support the science needed to help new drugs from cannabis. The agency believes the drug approval process represents the best way to ensure that safe and effective new medicines are available to patients in need of appropriate medical therapy.
For more information on DMFs and the guidance, the FDA has recorded a webinar, “Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations.” More questions and comments on the use of DMFs may be submitted to CDER’s Division of Drug Information at druginfo@fda.hhs.gov or by calling 855-543-3784 or 301-796-3400 or to the DMF mailbox dmfquestion@fda.hhs.gov.
For any other questions on this update or for questions on the drug approval process, please email mdi Consultants at info@mdiconsultants.com RE: DMF.