What is a Drug Master File (DMF) used for?

A Drug Master File (DMF) serves as a confidential repository for detailed information about specific aspects of drug manufacturing and formulation. It is submitted to the FDA to provide necessary technical information that can support the approval of a drug product without the need for the applicant to disclose proprietary information publicly. This may include data related to the facilities, processes, packaging, or raw materials used in the production of pharmaceuticals.

By maintaining this confidentiality, a DMF allows companies to safeguard sensitive business information while still complying with regulatory requirements. This is particularly important for manufacturers who supply components or materials to a drug product developer, as their proprietary methods and formulations are protected.

Other choices focus on different regulatory processes. Project proposals and registering new drugs involve distinct submission forms and processes within the FDA structure, while documenting clinical trial findings pertains to clinical data submissions rather than the manufacturing details covered in a DMF. Thus, the primary purpose of a DMF is to ensure that the FDA has access to necessary manufacturing information while protecting proprietary data.