Public Meeting on
The FDA Modernization Act of 1997 (FDAMA)
Section 406(b)

September 14, 1998
9:00 a.m. - 1:00 p.m.
Bethesda Holiday Inn
Bethesda, Maryland 20814

Agenda

9:00 - 9:15 a.m. Introductions and Opening Remarks

Moderator: Linda Suydam, Associate Commissioner for Strategic Management, FDA

FDA Panel
Robert J. Byrd, Deputy Commissioner for Management and Systems
Sharon Smith Holston, Deputy Commissioner for External Affairs
Daniel L. Michels, Director, Office of Enforcement, Office of Regulatory Affairs
Bernard A. Schwetz, DVM, Ph.D., Interim Chief Scientist
William B. Schultz, Deputy Commissioner for Policy

9:15 - 1l:00 a.m. Panel I

Carl F. Dixon, President and Executive Director, Kidney Cancer Association
Robin A. Harrison, Director, Diabetes Consumer Cooperative
Michael Havlicek, President, Amyotrophic Lateral Sclerosis Association
Millicent Gorham, Executive Director, National Black Nurses Association and
Member of the FDA Consumer Consortium
David Nelson, Senior Director for Special Initiatives, National Mental Health Association Diane Griffith, Congressional Liaison, Breast Implant National Support Organizations

** A 15-minute break will be provided during this panel session

11:00 - 12:00 noon Panel II

Bert Spilker, Ph.D., M.D., Senior Vice President, Scientific and Regulatory Affairs, PhRMA
Stephen J. Northrup, Executive Director, Medical Device Manufacturers Association
Susan K. Zagame, Vice President for Technology & Regulatory Affairs, HIMA
Representative, American Association of Blood Banks

12:00 - 12:30 p.m. Open Session

12:30 - 1:00 p.m. Summation and Closing Remarks

Linda Suydam, Associate Commissioner for Strategic Management, FDA

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