FDA/CMS Summit Dec. 11, 2012 Generic Drugs and GDUFA Panel to be Moderated by Catalyst

Catalyst President Nancy Bradish Myers will serve as moderator for a panel on “The New Generic Drug Era” at The Pink Sheet and the RPM Report’s FDA/CMS Summit on Dec. 11. The panel will focus on the significant changes to come under the recently passed Generic Drug User Fee Act, for example the increased focus on global manufacturing quality. Panelists will include Gregory Geba, Director of FDA’s Office of Generic Drugs; Gary Buehler, former OGD Director and currently VP-Teva Pharmaceuticals; Ralph Neas, President and CEO of the Generic Pharmaceutical Association; and an investigator within FDA’s Office of Regulatory Affairs. For more information, see the draft agenda.