FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
| Agency | Date | Time | Location |
|---|---|---|---|
| FDA | April 22, 2004 | 8 a.m. - 5 p.m. | Food
and Drug Administration |
| 8:00 a.m. | Call
to Order Kenneth I. Shine, M.D., Chair, FDA Science Board |
| 8:15 a.m. | Welcome
and opening remarks Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA |
| 8:30 a.m. | Overview
of the FDA Initiative on Obesity Robert E. Brackett, Ph.D., Director, Center for Food Safety & Applied Nutrition, FDA |
| 8:40 a.m. | Obesity
- Therapeutics David G. Orloff, M.D., Director, Division of Metabolic and Endocrine Drugs, ODE II, Office of New Drugs, Center for Drug Evaluation & Research, FDA |
| 9:00 a.m. | Obesity
- Research David W.K. Acheson, M.D., Director, Food Safety and Security Staff, Center for Food Safety & Applied Nutrition, FDA |
| 9:20 a.m. | Break |
| 9:45 a.m. | Highlights
of the Obesity Working Group Report Alan M. Rulis, Ph.D., Director, Office of Food Additive Safety, Center for Food Safety & Applied Nutrition, FDA |
| 10:15 a.m. | Questions and Discussion with the Board/Presenters |
| 10:45 a.m. | Update
on ORA Peer Review John R. Marzilli, Deputy Associate Commissioner for Regulatory Affairs, FDA |
| 11:00 a.m. | Open Public Hearing |
| 12:15 p.m. | Lunch |
| 1:15 p.m. | Introduction
to Critical Path Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA |
| 2:00 p.m. | Perspective
on Anti-infectives and Vaccines Gail H. Cassell, Ph.D., Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company |
| 2:20 p.m. | Perspective
on Chronic Disease Therapies Robert M. Califf, M.D., Associate Vice Chancellor for Clinical Research and Director, Duke Clinical Research Institute, Duke University Medical Center |
| 2:40 p.m. | Drug
Formulation and Development, and Tissue Engineering Issues Robert S. Langer, Sc.D., Kenneth J. Germeshausen Professor of Chemical and Biomedical Engineering, MIT |
| 3:00 p.m. | Break |
| 3:20 p.m. | Overview
of Opportunities- Drugs Robert Temple, M.D., Director, Office of Medical Policy, Center for Drug Evaluation & Research, FDA |
| 3:40 p.m. | Overview
of Opportunities- Devices Larry G. Kessler, Sc.D., Director, Office of Science and Engineering Laboratories, Center for Devices & Radiological Health, FDA |
| 4:10 p.m. | Overview
of Opportunities- Biologics Jesse Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation & Research, FDA |
| 4:30 p.m. | Questions and Discussion with Board – Recommendations |
| 5:00 p.m. | Adjourn |