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FDA Official and Title | Date and Site | Other FDA Participants | Non-FDA Participants | Subject |
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Michael A. Friedman,MD Acting Commissioner | 7/6 FDA-Rockville | Sharon Smith Holston, Deputy Commissioner for External Affairs; Melinda Plaisier, Office of Legislative Affairs; and others | Alan Holmer, President; Russ Bantham, General Counsel; Bert Spilker, VP for Scientific & Reg. Affairs (all from PhRMA) | Discussion of several topics (minutes are available) | |
Michael A. Friedman,MD Acting Commissioner | 7/9 Capitol Hill | Diane Thompson, Assoc. Cmsr. For Legislative Affairs | Senator Bingaman; and others | Courtesy Visit (no minutes available) | |
Dr. Stuart L. Nightingale, Associate Commissioner for Health Affairs | 6/26 Rockville | Janet Showalter | Bert Spilker, Senior Vice President, Scientific and Regulatory Affairs, PhRMA; Carole McCullough, PhRMA; Alex Giaquinto (by phone), Senior Vice President , World Wide Regulatory Affairs, Schering Plough Corporation | Courtesy visit to exchange general information about the AMA, World Medical Association, Product Availability issues and ICH. | |
Dr. Kathryn C. Zoon, Director, CBER | 7/8 Bethesda, MD | CBER Therapeutics regulatory Staff | EntreMed John W. Holaday, Edward R. Gubish, Kim Lee Sim, and others; James Pluda, NCI/NIH | Broad discussion of product licensing procedures | |
Joseph A. Levitt, Director, CFSAN | 6/18 Room 6821 | Catherine J. Bailey | National Food Processors Association (NFPA) Rhona Applebaum, Kelly Johnson, and Scott Miller | Food additive approval proposal |
July 15, 1998