Drug Master Files and cGMP

This presentation will provide an overview of Drug Master Files (DMF).  A DMF contains confidential information that is filed with a regulatory agency.  It allows the regulatory agency to view confidential detailed information in connection with a sponsor’s marketing application.

The discussion will include:  types of DMFs, importance and value of DMFs (in protecting confidential information), and the role that DMFs have in the FDA’s regulatory review and approval process for drugs and biologics.

There will be an emphasis on the importance of the role of suppliers to the drug industry relative to the preparation and maintenance of DMFs.

Focus will be primarily on referenced, documented and expressed views from U.S. FDA to assist in facilitating understanding of the purpose and benefits of DMFs.

The presentation also will highlight the use of current Good Manufacturing Practices (cGMPs) for products that are used in this regulated industry, and how cGMPs assist in assuring safety and efficacy.