Placement of DMF Reference Letters

Rather than submit key information in Module 3 of an application (ANDA, BLA, IND, or NDA), it’s become increasingly common for sponsors to reference a Drug Master File (DMF). Referencing a DMF allows the component manufacturer of the drug or biologic to share proprietary information with the US FDA without having to directly share the … Continued

Rules for Submitting Electronic DMFs to FDA, Health Canada

  Rumors of rules governing Drug Master File (DMF) submissions are swirling. I’ve heard a pair of questions lately. “Do I need to resubmit my DMF files in eCTD format?” “Should I resubmit my files electronically?” The answer depends on the agency. The U.S. FDA and Health Canada have each updated their submission requirements for … Continued

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