Recent Changes in U.S. Food and Drug Law: Implications for Drug Development

Abstract

This paper examines in detail the Waxman/Hatch Act and the NDA Rewrite, from both an implementation point of view and from a world-wide research and development perspective. The central theme of these regulatory changes appears to be consistent with U.S. drug policy of the past two decades, i.e., cost containment, primarily, followed by uniformity and efficiency in the regulatory review process. These recent changes, just as the 1962 Drug Ammendments 22 years earlier, will continue to have profound effects upon the sites at which pharmaceutical research and development is carried out.