FDA Science Board Meeting
October 25, 2002
5630 Fishers Lane, Room 1066

8:00 a.m. – 4:30 p.m.

8:00 a.m.         Call to Order
                        Robert S. Langer, Sc.D., Science Board Chair

            Introductory Remarks
            Lester Crawford, D.V.M., Ph.D., Deputy Commissioner, FDA

            Introductory Remarks
                        Norris E. Alderson, Ph.D., Senior Associate Commissioner for Science & Health

 8:30 a.m.        Counter Terrorism Initiatives at FDA
Andrea Meyerhoff, M.D., Director, Counter Terrorism Programs, Office of the                         Commissioner

                        Food Safety - Counter Terrorism Initiatives
Joseph Levitt, Esq., Director, Center for Food Safety & Applied Nutrition                            (CFSAN)  

9:30 a.m.         Discussion
Science Board Members

 10:00 a.m.      Break

 10:15              Office of Cellular, Tissue, and Gene Therapies (OCTGT)
                       Kathryn Zoon, Ph.D., Director, Center for Biologics Evaluation & Research                        (CBER)

Philip Noguchi, M.D., Director, OCTGT               

 11:00 a.m.     Discussion
Science Board

11:30 a.m.     Update on Management Oversight of Products
Murray Lumpkin, M.D., Senior Associate Commissioner

12:00 p.m.      Break for Lunch                                                             

1:00 p.m.        Open Public Comment

2:00 p.m.         Pregnancy Labeling/Research & Study Design on Medications Used by   Pregnant Women

                        Susan Wood, Ph.D., Director, Office of Women’s Health (OWH), Office of the Commissioner

                        Margaret Miller, Ph.D., Manager Science Programs, OWH

                       Kathleen Uhl, Ph.D., Medical Officer, Pregnancy Labeling Team, CDER

3:00 p.m.        Discussion
Science Board Members

 3:30                Pharmaceutical cGMPs Initiative (Update)
                        Janet Woodcock, M.D., Director, Center for Drug Evaluation & Research                            (CDER)

 4:15 p.m.        Discussion
Science Board Members

4:30 p.m.         Science Board Closing Remarks/Future Direction