Generic Pharmaceutical Association/Office of Generic Drugs Joint Meeting: June 26, 2003

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FDA/Center for Drug Evaluation and Research

June 26, 2003
7500 Standish Place, Rockville, MD
Conference Room B

8:30 – 9:15 Welcome & Updates	Helen Winkle Presentation Gary Buehler Presentation
9:15 – 9:40 Therapeutic Inequivalency Action Coordinating Committee	Robert King Ph.D. Presentation
9:40 – 10:00 OGD Research Update	Lawrence Yu, Ph.D. Presentation
10:00 – 10:15 Break
10:15 – 11:00 Bioequivalence Review Issues,	Dale Conner Presentation
11:00 – 11:15 Clinical Review Update	Dena Hixon, M.D. Presentation
11:15 – 11:30 Q & A (AM Presentations)
11:30 – 12:45 Lunch On Your Own
12:45 – 1:30 Microbiology Review Issues	Neal Sweeney, Ph.D. Presentation
1:30 – 2:30 Chemistry Review Issues	Paul Schwartz, Ph.D. Presentation Vilayat Sayeed, Ph.D. Presentation
2:30 – 2:45 IT Update	Ruth Warzala Presentation
2:45 - 3:00 Break
3:00 – 4:00 DLPS Review Issues	Filing, Paras Patel Presentation Labeling Review, Ruby Wu Presentation Review Management, Tim Ames Presentation
4:00 – 5:00 Q & A - Next Steps	All

Date created: July 15, 2003; Last Updated: July 16, 2003