title: The critical path initiative: leveraging collaborations to enhance regulatory science.
abstract: Since 2004, the Critical Path Initiative has prompted industry, academia, and government agencies to work together to share the information, technology, and expertise critical to modernize and transform our approach to drug development and review. Various collaborations have been sharing data in a precompetitive space, establishing data standards, and facilitating collective tool development. As a result, the organization is making progress toward developing knowledge and tools that can reduce uncertainty in medical product development.
authors.affiliation: Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Barratt
authors.forename: S L
authors.initials: SL
authors.lastname: Bowens
authors.forename: S K
authors.initials: SK
authors.lastname: McCune
authors.forename: J N
authors.initials: JN
authors.lastname: Johannessen
authors.forename: S Y
authors.initials: SY
authors.lastname: Buckman
mesh_terms: D000818:Animals; D003299:Cooperative Behavior; D019091:Critical Pathways; D055808:Drug Discovery / Q000379:methods*; D004335:Drug and Narcotic Control / Q000379:methods*; D006801:Humans; D007221:Industry / Q000379:methods*; D012586:Science / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration