FDA Science Board Advisory Committee Meeting

November 5, 2004

5630 Fishers Lane, Room 1066

8:00 a.m. Call to Order

Kenneth I. Shine, M.D., Chair, FDA Science Board

Meeting Statement

Jan N. Johannessen, Ph.D., Executive Secretary

8:10 a.m. Welcome and opening remarks

Lester M. Crawford, D.V.M., Ph.D., Acting Commissioner of Food and Drugs

8:25 a.m. Update on the Critical Path Initiative

CDER Critical Path Activities

Douglas Throckmorton, M.D., Center for Drug Evaluation and Research, FDA

CBER Critical Path Activities

Jesse Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation and Research, FDA

CDRH Critical Path Activities

Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA

Overview of Critical Path Docket Submissions

Lisa Rovin, J.D., Director, Critical Path Initiative, Office of the Commissioner, FDA

9:30 a.m. Break

9:45 a.m. Critical Path - Current Activities and The Path Forward

Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA

10:15 a.m. Medical Technology Innovation Task Force

Larry G. Kessler, Sc.D., Director, Office of Science and Engineering Laboratories,

Center for Devices and Radiological Health, FDA

10:45 a.m. Foods Critical Path White Paper

Alan M. Rulis, Ph.D., Senior Advisor for Special Projects, Center for Food Safety and Applied Nutrition, FDA

11:00 a.m. Questions and Discussion with the Board/Presenters

12:00 p.m. Lunch

1:00 p.m. Open Public Hearing

2:00 p.m. Pharmaceutical cGMP Initiative

Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA

Final Report on Process Analytical Technology and Manufacturing Science

Ajaz Hussain, Ph.D., Deputy Director, Office of Pharmaceutical Sciences, CDER, FDA

3:30 p.m. Break

3:45 p.m. ORA Peer Review – Overview of Report and Plan for External Peer Review

John R. Marzilli, Deputy Associate Commissioner for Regulatory Affairs, FDA

4:30 p.m. Questions and Discussion with Board – Recommendations

5:00 p.m. Adjourn