Promoting, improving and accelerating the drug development and approval processes

Three programs originating at drug regulatory agencies have been set up with the objective of facilitating, potentiating and accelerating the development of new medicines. The U.S. FDA and EMEA have introduced a new phase of clinical testing designed to ease the transition from lab to clinic, known as microdosing in Europe and as phase 0 in the United States. Orphan drug programs have been established in the U.S., E.U., Japan and Australia to encourage the development of medicines to treat rare diseases. The FDA's fast track development program was set up to facilitate the development and expedite the review of drugs that treat a broad range of serious diseases and fill an unmet medical need. This article reviews the three programs and provides a capsule view of new developments in these vital areas during the year 2006.