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U.S. Department of Health and Human Services

Drugs

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CDER Small Business Webinar on the Guidance for Industry - Time and Extent Applications for Nonprescription Drug Products (2011) - April 16, 2012

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 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, April 16, 2012, we presented our webinar entitled Guidance for Industry - Time and Extent Applications for Nonprescription Drug Products (2011), which discussed the various regulatory elements of the guidance and the submission process.

Our presenter was Dr. Ruth Scroggs, Lead Interdisciplinary Review Scientist/Pharmacist in the Division of Nonprescription Regulation Development (DNRD).Dr. Scroggs is a registered pharmacist who has been with FDA for ten years. She currently serves as DNRD Team Leader in OTC Monograph development for the Gastrointestinal, Urologic, and Reproductive Health Team.  Prior to this position, she was a Review Scientist within DNRD during which time she was able to facilitate the September 2011 publication of the final Guidance for Industry- Time and Extent Applications for Nonprescription Drug Products. Also, in 2011, she was recognized with FDA Honor and Center Director Awards for her efforts in advancing sunscreen regulations to publication. Before DNRD, Dr. Scroggs was a Safety Evaluator in the Division of Pharmacovigilance II within the Office of Surveillance and Epidemiology.  Earlier in her FDA career she served as a Regulatory Health Project Manager in the Division of Gastrointestinal Products having started her FDA career as a Consumer Safety Officer in the former Division of Gastrointestinal and Hematology Drug Products.  She received her Doctor of Pharmacy degree from the University of Maryland College of Pharmacy and BS Pharm from the University of Arkansas for Medical Sciences College of Pharmacy. 

For More Information:
http://www.fda.gov/smallbusinessdrugs

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