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Transparency Public Meeting: November 3, 2009


June 24, 2009 Public Meeting

Transparency Report Arrow November 3, 2009 Public Meeting

Meeting Transcript

Below is a link to the complete meeting transcript from the public meeting on November 3.

Hypothetical Case Studies

Below are links to the complete hypothetical case studies discussed by participants at the public meeting on November 3.

November 3 Public Meeting Agenda


9:00 AM      Welcome and Introductions

9:15 AM  Discussion Group 1:  Emerging safety issues concerning FDA-regulated products.
  • Tony Corbo, Senior Lobbyist, Food & Water Watch
  • AnnaMaria DeSalva, Worldwide Director of Healthcare, Hill and Knowlton
  • Barry Dickinson, Secretary to the Council on Science and Public Health, American Medical Association
  • Larry Kohl, Senior Director for Food Safety Programs, Food Marketing Institute
  • Sarah Klein, Food Safety Staff Attorney, Center for Science in the Public Interest
  • David Spangler, Senior Vice President, Policy & International Affairs, Consumer Healthcare Products Association
10:30 AM Break

10:45 AM Discussion Group 2:  Product applications that are abandoned or withdrawn by the applicant before approval.
  • Kalah Auchincloss, Associate, Foley Hoag LLP
  • Ekopimo Ibia, Director, Global Medical and Regulatory Policy, Merck
  • Heather Nigro, Regulatory Affairs Manager, Covidien
  • Diana Zuckerman, President, National Research Center for Women & Families


12:00 PM     Lunch (on your own)

1:00 PM

Discussion Group 3:  Agency decisions about pending product applications.

  • Michael Hinckle, Partner, K&L Gates LLP, on behalf of the Generic Pharmaceutical Association (GPhA)
  • Richard J. Martin, Senior Legislative and Regulatory Analyst, American Society for Radiation Oncology
  • James Dabney Miller, Visiting Scholar, Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health
  • Nirmal Mulye, President and Founder, Nostrum Pharmaceuticals, LLC


2:15 PM   Open Public Comment

3:00 PM  Meeting Adjourns