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FDA PUBLIC CALENDAR

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.

	October 17, 2005
FDA Official and Title	Date and Site	Other FDA Participants	Non-FDA Participants	Subject
Robert E. Brackett, Director, CFSAN	7/25/05, Parklawn Bldg., Room 14-94	Laura Tarantino, Director, Carrie Hendricks, Carrie Hendrickson, OFAS; Samir Assar, EOS detailee)	Martek Biosciences Corporation Sam Seller, Director, Regulatory Affairs, Edward B. Nelson, Vice President, George Barker, General Counsel, Robert Edwards, Director of Regulatory Sciences, Arent Fox Attorneys at Law, Abby Brandel, Arent Fox, and Steve Abrams, Professor, Baylor	To discuss Gras Notice Number GRN-00094
Janice Oliver, Deputy Director	9/26/05, Wiley Building, College Park, MD	Don Kraemer, Acting Director, Office of Seafood (OS) and Tim Hansen, Supervisory Consumer Safety Office (OS)	David Burney, US Tuna Foundation; Chris Lischewski, Bumble Bee Foods; Jeffrey Watters, StarKist; John W. Bode, Olsson, Frank and Weeda; Randi Thomas, Us Tuna Foundation; and John Signorini, Chicken of the Sea	To discuss the Regulatory and Food and Safety issues related to tuna.
Jesse L. Goodman, MD, MPH, Director, CBER	9/29/05 Bethesda, MD	Kathryn C. Carbone, MD, Associate Director for Research,CBER	Research Review Subcommittee of Cellular, Tissue and Gene Therapies Advisory Committee Site Visit Members of the AC	Research programs in the Division of Cellular and Gene Therapy, relevance to the regulatory mission and relation to Critical Path needs. Drs. Goodman and Carbone presented an overview.
Jesse L. Goodman, MD, MPH, Director, CBER	9/29/05 Washington, DC	Other staff from DHHS	HIV Medicine Association staff	Review current issues
Janet Woodcock, M.D., Deputy Commissioner for Operations	10/4/05 Washington, DC	Robert Temple, MD	Professor Stuart Walker, CMR International Peter Corr, MD Senior Vice President for Science and Technology, Pfizer Dr. Outi Maki-ikola, European Medicines Agency Dr. Eiry Roberts, Eli Lilly	New Paradigm for Clinication Research Speaker A New Paradigm for Clinical Development?  Role of FDA’s Critical Path Initiative
Janet Woodcock, M.D. Deputy Commissioner for Operations	10/5/05 Bethesda, MD	Ajaz Hussain, PhD John Simmons, Ph.D Moheb Nasr, Ph.D Helen Winkle	John Berridge, Pfizer Steve Poehlein, Merck & Company	AAPS/FDA Speaker – Pharmaceutical Quality in the 21st Century – An Integrated System Approach
Janet Woodcock, M.D. Deputy Commissioner for Operations	10/6/05 Bethesda, MD	Felix Frueh, PhD Larry Lesko, PhD David Jacobson-Kram	Professor Lindpaintner, E-Hoffman-La Roche, Switzerland Christopher Webster, PhRMA	DIA/FDA Speaker – Importance of Genomic Biomarker Validation in the Context of Pharmacogenomic Initiatives at the FDA
Janet Woodcock, M.D. Deputy Commissioner for Operations	10/11/05 Bethesda, MD	Doug Throckmorton, CDER Robert Temple, CDER Mark Kramer, OD	Mitch Krucoff, Duke Marilyn Agin, Pfizer Philip Sager, Astra Zeneca Robert Califf, Duke	ECG Warehouse Meeting Speaker – Update on Critical Path
Margaret Glavin, Associate Commissioner of Regulatory Affairs	10/6/05	None	None	Meet and Greet with Swiss Medic
Jesse L. Goodman, MD, MPH, Director, CBER	10/11/05 Laguna Niguel, CA	Other staff from DHHS	Unknown Conference attendees for Biotech Meeting	Participant in the "FDA Break Out Session" representing CBER
Margaret Glavin, Associate Commissioner of Regulatory Affairs	10/11/05	Mike Taylor	None	FSRC Conference
Robert E. Brackett, Director, CFSAN	10/18/05, Harvey Wiley Building, College Park, MD	Catherine Copp, Office of Regulations and Policy; Felicia Billingslow, ONPLDS, CFSAN; Terry Troxell, Director of OPDF; Nega Beru; Robert Buchanan, Director, OSCI; and Nathan Sabel, Office of Chief Counsel	Guy Shoemaker, Horizon Milling/Cargill; Elizabeth Faga, President of NAMA; Brent Baglieu, ConAgra Milling; Paul Maass, ConAgra; Jane DeMarchi, James Bair, Vice President, NAMA; and Craig Fisher, ADM Milling	To discuss Allergen Labeling issues as they apply to Milled Products
Michael Landa, Deputy Center Director for Policy and Regulations	10/18/05, Harvey Wiley Building, College Park, MD	Donald Kramer, Office of Seafood; John Jones, OIP; Robin Woo, IAS; CFSAN, Merton Smith, and Fran Pell, CVM; Joseph Baca, Director, Office of Compliance	Mrs. Tran Bich Nga, Vice Director, National Fishery Quality Assurance and Vet. Dept.; Mr. Nguyen Nhu Tiep, Vet. Manager; and Mr. Le Dihn Hung, Director, Quality Center	To discuss the use of antibiotics in aquiculture, description of port inspection and laboratory analysis

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