Food and Drug Law Institute: Annual Meeting to feature panel on user fee program negotiations

Moderated by Catalyst President Nancy Bradish Myers, this panel will explore lessons learned from the prescription drug and medical device user fee program negotiations (PDUFA and MDUFA), and how those lessons may inform others as they consider their user fee negotiation strategies. The panel will feature insights from experts, including both current and former negotiators, representing FDA, the biopharmaceutical industry, and the medical device industry, as well as patient advocacy organizations.

Moderator: Nancy Bradish Myers, JD
President, Catalyst Healthcare Consulting

Speakers/panelists:
Diane Dorman
VP Public Policy – National Organization for Rare Disorders (NORD)

Timothy Franson, MD
Senior VP – B&D Consulting

Alan Goldhammer, PhD
Drug Regulatory Consultant, Alan Goldhammer, LLC

Stephen J. Northrup, MPA
Principal, The Podesta Group

Janet Woodcock, MD
Director, Center for Drug Evaluation and Research, FDA

The panel will be held April 5, 2011, during the FDLI annual meeting in Washington, DC. More information on is available at http://www.fdli.org/conf/annual/11/agenda.html