Cut Drug Approval Time


Cut Drug Approval Time:
Is A 505(b)(2) the Right Way to Go

Your office, March 25, 2014


Meet your instructors

Kurt Karst, a Director with Hyman, Phelps & McNamara, is a widely respected legal authority and blogger on 505(b)(2) issues. Karst provides regulatory counseling to pharmaceutical manufacturers concerning Hatch-Waxman patent and exclusivity issues, myriad drug development issues, pediatric testing issues and orphan drug issues. Previously, he was a lobbyist for F. Hoffman-La Roche Inc.

Mr. Karst served as an articles editor for the American University Law Review, and in 1995, was awarded a Fulbright Scholarship for post-graduate studies in Germany. He has published in the American University Law Review, the Food and Drug Law Journal and Update, RAPS FOCUS and many other publications, and is co-author of the Food and Drug Law Institute's Drug and Biologic Approvals: The Complete Guide for Small Businesses — FDA Financial Assistance and Incentives.