Welcome and Introductory Comments
Joshua Sharfstein, MD, Principal Deputy Commissioner
Afia Asamoah, JD, MPP, Special Assistant to Principal Deputy Commissioner

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, PhD, Secretary to the Council on Science and Public Health, American Medical Assoc.
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 & Int'l Affairs, Consumer Healthcare Products Assoc

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Click here to download case study Scenario 2

Discussion Group 2: Product applications that are abandoned or withdrawn by the applicant before approval.
Kalah Auchincloss, Associate, Foley Hoag LLP
Ekopimo Ibia, MD, Director, Global Medical and Regulatory Policy, Merck
Heather Nigro, Regulatory Affairs Manager, Covidien
Jane Reese-Coulbourne, Interim Executive Director, Reagan-Udall Foundation

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Discussion Group 3: Agency decisions about pending product applications.
Michael Hinckle, Partner, K&L Gates LLP, on behalf of the Generic Pharmaceutical Association
Richard J. Martin, Senior Legislative & 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, PhD, President and Founder, Nostrum Pharmaceuticals, LLC
Patrick Brady, Manager, Science and Regulatory Policy, Eli Lilly and Company
Diana Zuckerman, PhD, President, National Research Center for Women & Families

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Open Comment Session