FDA and the University of Rhode Island College of Pharmacy to Hold Joint Interactive Forum on Generic Drugs

FDA and the University of Rhode Island College of Pharmacy will co-sponsor an interactive forum from June 30 through July 1, 2008 at the Hyatt Regency in Bethesda, Maryland on how and how not to communicate with FDA’s Office of Generic Drugs (“OGD”).  Forum presenters will also address how the legal landscape for generic drug companies has changed over the past few years following the enactment of the Medicare Modernization Act (“MMA”) in December 2003. A copy of the forum brochure is available here.  Forum presenters include an all-star cast from FDA, including OGD Director Gary J. Buehler and FDA’s Associate Chief Counsel for Drugs, Elizabeth H. Dickinson.  Hyman, Phelps & McNamara, P.C.’s Robert A. Dormer will present on post-MMA FDA decisions and related communications concerning 180-day generic drug exclusivity and other issues.