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FDA Official and Title | Date and Site | Other FDA Participants | Non-FDA Participants | Subject | |
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Daniel E. Troy, Chief Counsel | 5/15 Rockville, MD | Elizabeth Dickinson (by phone), Fred Ansell, Kim Dettelbach | Danielle Stinemetz, Ralph A. Mittelberger, James N. Czaban, Heller-Ehrman,; Richard S. Egosi, Debbie Jaskot, TEVA Pharmaceuticals | Discussion re: Tramadol ANDA approval issues | |
Daniel E. Troy, Chief Counsel | 5/16 FDA/Washington, DC | By Phone: Fred Ansell, Kim Detelbach, Elizabeth Dickinson, OCC; Virginia Beakes, CDER | Steven Giuli, Kathleen Jaeger, GPhA; Judith Milford, TEVA | Orange Book Patent Listings | |
Daniel E. Troy, Chief Counsel | 5/22 Rockville, MD | Annette Marthaler | Michael R. Bruno, II, Michael R. Bruno, Bruno Independent Living Aids; Fred Rikkers, Dennis J. Purtell; Whyte, Hirschboeck, Dudek | Enforcement Issue | |
Daniel E. Troy, Chief Counsel | 5/22 Rockville, MD | Annette Marthaler, Catherine Cook | Ludwig Simmett, Minitube of America; Fred Rikkers, Dennis J. Purtell, Whyte, Hirschboeck, Dudek | Technologic Developments in ART | |
Daniel E. Troy, Chief Counsel | 5/28 Rockville, MD | Kim Dettelbach, Fred Ansell, OCC; Jane Axelrad, Gary Buehler, CDER | Dr. Marc Kamin, Helen Torelli, J&J; Alan Bennett, Terry Coleman, Bennett, Turner & Coleman | Ultram | |
Daniel E. Troy, Chief Counsel | 5/30 FDA/Washington, DC | Karen Schifter, Mike Landa, Fred Ansell, Kim Dettelbach, Liz Dickinson (by phone) | Francis D. Cerrito, Pennie & Edmonds; Peter Mathers, Richard Morey, Kleinfeld, Kaplan & Becker | Omeprazole | |
Daniel E. Troy, Chief Counsel | 5/31 Philadelphia, PA | Federalist Society Members and Drug Industry | Gave a presentation on FDA issues | ||
Kathryn C. Zoon, Ph.D., Director, Center for Biologics Evaluation and Research | 5/10 Bethesda, MD | None | Wyeth Reps | Discussion of potential shortages due to Consent Decree | |
Kathryn C. Zoon, Ph.D., Director, Center for Biologics Evaluation and Research | 5/23 Washington, DC | None | BIO Reps | Discuss creation of new office: Cellular and Gene Therapy | |
Kathryn C. Zoon, Ph.D., Director, Center for Biologics Evaluation and Research | 5/23 Bethesda, MD | None | Wyeth Reps | Smallpox | |
Kathryn C. Zoon, Ph.D., Director, Center for Biologics Evaluation and Research | 5/28 Bethesda, MD | other FDA employees | CDC | Discuss Aventis Pasteur Smallpox Vaccine |
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