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Specializing in FDA Regulatory Matters

An Overview of Drug Master Files

Prepared by Albert Yehaskel, Independent Consultant, EAS Consulting Group, LLC.

January 18, 2018

Abstract

DMFs are regulatory submissions to FDA for drug substances, drug products, and/or container closures allowing FDA to review information such as confidential details about facilities, processes, components, or articles used in the manufacturing, processing, packaging, and storing of one or more APIs and/or human drugs.  DMFs are at the discretion of the DMF holder and provided in the absence of relevant information in the CMC section of an application.  These submissions support a third party’s application without revealing the information to the third party and maintains the confidentiality of proprietary information (e.g., a synthetic or manufacturing procedure) for the holder, allowing review of information by reviewers at FDA to support applications. The information contained in a DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA/BLA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, and any amendments and supplements to any of these applications.

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