| 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Discussion Group 2: Product applications that are abandoned or withdrawn by the applicant before approval.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
- Diana Zuckerman, President, National Research Center for Women & Families
|
| 2:15 PM |
Open Public Comment
|
| 3:00 PM |
Meeting Adjourns |
