Drug Master Files (DMFs) are confidential documents submitted to the FDA that contain detailed information about the facilities, processes, or articles involved in drug manufacturing. They allow different parties to reference critical information without having to disclose the contents of the DMF.
The FDA does not approve or disapprove DMFs; instead, it evaluates their technical content while reviewing related applications such as NDAs, ANDAs, INDs, or BLAs.
DMFs come in various types, each serving a specific purpose. These include information about manufacturing sites, drug substances, packaging materials, excipients, and other critical components. Proper organization and submission in the preferred ICH Common Technical Document (CTD) structure are crucial for regulatory acceptance.
Our expert team ensures accurate and timely submissions, professional electronic Common Technical Document (eCTD) publishing, and seamless dispatch through the FDA's Electronic Submission Gateway (ESG).
For more detailed information and concrete examples, please read the full article here:
https://www.productlifegroup.com/understanding-fda-drug-master-files-overview/
