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FDA PUBLIC CALENDAR

Food and Drug Administration
Office of Public Affairs
5600 Fishers Lane
Rockville, MD 20857

This public calendar is issued by the Food and Drug Administration. It lists meetings held by the FDA policy makers with persons outside the executive branch of the Federal Government.

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September 12, 2005

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FDA Official and Title

Date and Site

Other FDA Participants

Non-FDA Participants

Subject

Margaret Glavin, Associate Commissioner of Regulatory Affairs 8/25/05 None Booz-Allen OC Management Assessment
Margaret Glavin, Associate Commissioner of Regulatory Affairs 8/26/05 None None ICLN
Janet Woodcock, M.D.,
Deputy Commissioner for Operations
9/8/05
Rockville, MD
Don Stanski/ Robert Powell American Association of Pharmaceutical Scientists Biomarker Workshop
Speaker
Developing Disease Knowledge to Improve Drug Development and Individualize Therapy
Sheldon T. Bradshaw, Chief Counsel 9/7/05 FDA/Rockville, MD Marc Caden, Donna Katz, OCC Kate Beardsley, Carmen Shepard, Buc & Beardsley Issues related to client's application
Sheldon T. Bradshaw, Chief Counsel 9/7/05 FDA/Rockville, MD Elizabeth Dickinson, Eric Blumberg, Mark Raza, Shoshana Hutchinson, Ann Wion, Kim Dettelbach, Peter Beckerman, OCC John M. Engel, Gillian R. Woollett, Engel & Novitt, LLP Courtesy Visit: FDCA issues
Jesse L. Goodman, MD, MPH, Director, CBER 9/9/05 Bethesda, MD Diane Maloney, JD, Associate Director for Policy; Robert Yetter, PhD, Associate Director for Review Management; Mary Malarkey, Director, OCBQ, Jay Epstein, MD, Director, OBRR and other OBRR staff Unknown, other attendees Participate in annual Plasma Protein Therapeutics Association liaison meeting with CBER
Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine 8/12/05 Washington, DC Dr. Dan McChesney, Dr. Burt Pritchett, and Mr. Shannon Jordre Joel Newman, President; Richard Sellers, Vice President, Feed Control and Nutrition from American Feed Industry Assn. and other industry representatives BSE Roundtable Meeting
Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine 7/14/05 Rockville, MD Dr. Linda Tollefson, Dr. Dan McChesney, and Catherine Beck Tom Corcoran, FDAH; Dr. Bruce Burlington, Wyeth; Deborah Chaleff, FDAH; Gerald Fisher, FDAH, Rami Cobb, FDAH Update on Fort Dodge Animal Health (FDAH) issues and to discuss FY2006 ADUFA Fee Rates with Animal Health Institute (AHI)
Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine 7/19/05 Rockville, MD Dr. Dan McChesney Ken Baker, Pharmacy, Compounding Accreditation Board To discuss compounding issues
Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine 7/28/05 Rockville, MD Robert Miller Alex Mathews, AHI and Richard Carneval, AHI To discuss FY2006 ADUFA Fee Rates with Animal Health Institute (AHI)
Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine 6/22/05 Rockville, MD None Joel Newman, American Feed Industry Association Quarterly Meeting
Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine 6/24/05 Telecon None Dr. Bruce Burlington and Mr. Jeff Levitt, Wyeth Update on Wyeth related issues
Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine 5/9/05 None Dr. Bruce Burlington, Wyeth Update on Wyeth related issues
Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine 5/24/05 Rockville, MD Dr. Dan McChesney and Catherine Beck Dr. Bruce Burlington, Wyeth; Dr. Gerald Fisher, FDAH; Dr. Rami Cobb, FDAH; and E. Thomas Corcoran, FDAH Update on Fort Dodge Animal Health (FDAH) issues
Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine 5/31/05 Rockville, MD John Matheson, Larisa Rudenko, and Catherine Beck Connie Tipton, IDFA; Clayton Hough, IDFA; Chip Kunde, IDFA; and Marci Cleary Meeting with the International Dairy Foods Association to discuss the cloning risk assessment
Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine 4/20/05 Telecon Dr. George Graber Dr. Cleon Kimberling, Colorado State To discuss ID tracebacks and food safety

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