title: Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective.
abstract: Globalization of clinical research has led to an increase in clinical trials conducted outside of the United States that are submitted to the US Food and Drug Administration (FDA) in new drug applications. This article discusses the FDA's experience with these submissions in specific therapeutic areas, including the extent of this practice, differences between the effectiveness and safety outcomes of studies conducted inside and outside the United States, and the FDA's approach to acceptance of these trials.
authors.affiliation: Office of Drug Evaluation I, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. ni.khin@fda.hhs.gov
authors.forename: N A
authors.initials: NA
authors.lastname: Khin
authors.forename: P
authors.initials: P
authors.lastname: Yang
authors.forename: H M J
authors.initials: HM
authors.lastname: Hung
authors.forename: K
authors.initials: K
authors.lastname: Maung-U
authors.forename: Y-F
authors.initials: YF
authors.lastname: Chen
authors.forename: A
authors.initials: A
authors.lastname: Meeker-O'Connell
authors.forename: P
authors.initials: P
authors.lastname: Okwesili
authors.forename: S U
authors.initials: SU
authors.lastname: Yasuda
authors.forename: L K
authors.initials: LK
authors.lastname: Ball
authors.forename: S-M
authors.initials: SM
authors.lastname: Huang
authors.forename: R T
authors.initials: RT
authors.lastname: O'Neill
authors.forename: R
authors.initials: R
authors.lastname: Temple
mesh_terms: D014150:Antipsychotic Agents / Q000627:therapeutic use; D002317:Cardiovascular Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods* / Q000706:statistics & numerical data; D017277:Drug Approval / Q000458:organization & administration* / Q000706:statistics & numerical data; D017408:Guidelines as Topic; D006801:Humans; D038622:Internationality; D009965:Orphan Drug Production / Q000706:statistics & numerical data; D010601:Pharmacology, Clinical / Q000458:organization & administration; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration* / Q000706:statistics & numerical data
chemical_list: D014150:Antipsychotic Agents; D002317:Cardiovascular Agents