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U.S. Department of Health and Human Services

Drugs

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CDER Small Business Webinar on Drug Master Files (DMFs) under Generic Drug User Fee Amendments (GDUFA) - February 11, 2013

The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.

 
These focused webinars 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 February 11, 2013, the CDER Small Business Assistance Program presented a webinar entitled Drug Master Files (DMFs) under Generic Drug User Fee Amendment (GDUFA).
 
Purpose
This webinar addressed
  • Both general topics and specific GDUFA subjects that impact Drug Master Files (DMFs), with particular attention to Type II DMFs for Active Pharmaceutical Ingredients (APIs). 
  • General topics of interest will include available DMF resources, submission and maintenance requirements for DMFs, requesting preassigned DMF numbers, and electronic DMF submissions. 
  • GDUFA related topics covered will include when and how to pay DMF fees, new DMF GDUFA correspondence, and the Completeness Assessment process and expectations, including the recently published draft guidance. 
 
Presenters
The presentation consisted of three distinct segments. Subject matter experts in each of these areas presented and answered questions. Our presenters were:
  • Dr. Arthur Shaw is the Center for Drug Evaluation and Research’s (CDER’s) Drug Master File (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. David Skanchy has been with the Office of Generic Drugs (OGD) since he arrived at FDA in 2002, serving in various positions throughout the Chemistry Review Divisions as both a reviewer and team leader. He currently serves as the Director of the newly formed Drug Master File (DMF) Review Staff and played a significant role in implementation of many of the new GDUFA requirements for DMFs. David holds a Ph.D. in Pharmaceutical Chemistry from the University of Kansas.
  • Dr. Huyi Zhang received his Ph.D. in Medicinal Chemistry and Bachelor of Pharmacy from Peking University Health Science Center (formerly Beijing Medical University) and did his postdoctoral training in Organic Synthesis at Worcester Polytechnic Institute. In 2010, Dr. Zhang joined FDA’s Office of Generic Drugs (OGD) as a Science Staff. He then moved to the Drug Master File (DMF) Review team in 2011, and currently serves as Acting Deputy Director of DMF Review Staff.    
For More Information:
http://www.fda.gov/smallbusinessdrugs
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