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U.S. Department of Health and Human Services


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Introduction to the Drug Master File (DMF) Webinar - November 14, 2011


The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is delighted to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series will highlight various aspects of drug regulation.
These focused webinars will support the Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business with information relating to the development and regulation of human drug products.
On Monday, November 14, 2011, we presented our webinar entitled Introduction to the Drug Master File (DMF) which discussed all aspects of filing a DMF, including when and why to submit a DMF; requirements and recommendations for formatting and submitting original DMFs and subsequent submissions; how DMFs are reviewed and common problems.
Our presenter was Dr. Arthur Shaw who is CDER’s DMF Expert, in addition to being a Quality Reviewer in the Office of New Drug Quality Assessment (ONDQA).  He has extensive experience in dealing with DMF filing and database issues, as well as reviewing many DMFs for technical content as part of his daily review work to support New Drug Applications (NDAs) and Investigational New Drug (IND) applications.
Dr. Shaw’s previous positions in FDA include Special Assistant in the Office of New Drug Chemistry and Review Chemist in the Division of Gastrointestinal and Coagulation Drug Products and in the Division of Pulmonary and Allergy Drug Products. Dr. Shaw received a B.S. in chemistry (with Honors) from the City College of New York and a Ph.D. in biochemistry at Cornell University.
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