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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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April 26, 2004

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FDA Official and Title

Date and Site

Other FDA Participants

Non-FDA Participants

Subject

Dr. Lester Crawford, Acting Commissioner of Food and Drugs

4/19/04 Washington, DC

Dan McChesney, Kristy Moran

John A. Sadduck, DVM., PhD., Sadduck Consulting, LLC; Ghana R. Kaulius, Legislative Advisor to Optibrand; Gary C. Smith, Monfort Professor of Meat Science, Colorado State University

To discuss identification and traceability systems for animals.

Amit Sachdev, Deputy Commissioner for Policy

4/15/04 Rockville, MD

Janet Woodcock, Scott Gottlieb, Larry Lesko, Shiew-Mei Huang, Mark Goldberger, Ajaz Hussain

Gregg Alton, Norbert Bischofberger, Gilead Sciences; Peter Honig, Robin Isaacs, Jeffrey Sturchio, Merck; Mark Speaker, Margo Heath-Chiaz, Bristol-Myers Squibb

HIV/AIDS

Amit Sachdev, Deputy Commissioner for Policy

4/19/04 Rockville, MD

Dan Troy, Steven Niedelman, Jeff Shuren, Charles Prettyman, Rick Blumberg, Louisa Nickerson, Indya Mungo

Michael McGuffin, President American Herbal Products Association (AHPA), Tony Young, Kleinfield, Kaplan & Becker, AHPA General Counsel Wilson Lau; Nuherbs Company Mark Thoman; McDermott, Will & Avery, Counsel to the Association of Acupuncture & Oriental Medicine

To discuss AHPA's and AAOM's Petition for Reconsideration and Petition for Stay.

Murray M. Lumpkin, M.D., Acting Deputy Commissioner for International & Special Programs

4/23/04 Rockville, MD

None

German Bundestag Cmte for Consumer Protection, Food & Agriculture: Ulrike Hofken, Manfared Helmut Zollmer, Peter Bleser, Marlene Mortler, Hans-Michael Goldman, Walraud Wolff, Werner Gueth; Embassy of Germany, Friedrich Wacker

BSE Bio-technology

Robert F. Brackett, Director, Center for Food Safety and Applied Nutrition

4/19/04 Washington, DC

Nina Adler, Bob Merker,CFSAN; John Levchuk, Center for Biologics; Paul Stavanic, Center for Drugs

American Air Liquide, Henry Ledon, James Yauan

Discuss Sterile Gas through filtration

Daniel E. Troy, Chief Counsel

4/19/04 Washington, DC

Coleen Klasmeier, Catherine Cook, OCC

Kate Beardsley, Carmen Shepard, Buc & Beardsley; Richard Russo, Marilyn Murray, Osteotech

Demineralized Bone Matrix products

Daniel E. Troy, Chief Counsel

4/21/04 Rockville, MD

Rick Blumberg, Kim Dettelbach, Elizabeth Dickinson, Karen Schifter, OCC

Peter Safir, Covington & Burling; Greg Diskant, Patterson Belknap; Russ Deyo, Taysen Van Itallie, Johnson & Johnson

Alza/Fentanyl

Daniel E. Troy, Chief Counsel

4/22/04 Rockville, MD

Rick Blumberg, Kim Dettelbach, Elizabeth Dickinson, Karen Schifter, OCC

Stuart Williams, Brian Roman, Jill Ondos, Mylan; Tony Figg, Joe Hynds, Rothwell, Figg

Mylan's Fentanyl ANDA

Daniel E. Troy, Chief Counsel

4/22/04 Rockville, MD

Dave Read, Cecelia Parise, Peter Rickman, Don O-Hare, Rita Hassall, OGC; Kim Dettelbach, Elizabeth Dickinson, Barr Weiner, OCC

Michael Gollen, David Adams, Todd Halpern, Venable; Michael Davitz, Alexander Cossen, Taro

Taro Pharmaceuticals/ANDA issues

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