title: The FDA critical path initiative and its influence on new drug development.
abstract: Societal expectations about drug safety and efficacy are rising while productivity in the pharmaceutical industry is falling. In 2004, the US Food and Drug Administration introduced the Critical Path Initiative with the intent of modernizing drug development by incorporating recent scientific advances, such as genomics and advanced imaging technologies, into the process. An important part of the initiative is the use of public-private partnerships and consortia to accomplish the needed research. This article explicates the reasoning behind the Critical Path Initiative and discusses examples of successful consortia.
authors.affiliation: Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857, USA. Janet.Woodcock@fda.hhs.gov
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
authors.forename: Raymond
authors.initials: R
authors.lastname: Woosley
mesh_terms: D003299:Cooperative Behavior; D017277:Drug Approval / Q000458:organization & administration*; D004345:Drug Industry; D006801:Humans; D007373:Interinstitutional Relations; D012106:Research / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration