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Regulatory and Scientific Issues Regarding Use of Foreign Data in Support of New Drug Applications in the United States: An FDA Perspective
Author(s) -
Khin N A,
Yang P,
Hung H M J,
MaungU K,
Chen YF,
MeekerO'Connell A,
Okwesili P,
Yasuda S U,
Ball L K,
Huang SM,
O'Neill R T,
Temple R
Publication year - 2013
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2013.70
Subject(s) - food and drug administration , clinical trial , clinical pharmacology , medicine , regulatory science , drug , clinical research , perspective (graphical) , pharmacology , drug approval , alternative medicine , engineering ethics , family medicine , medical education , computer science , engineering , pathology , artificial intelligence
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. Clinical Pharmacology & Therapeutics (2013); 94 2, 230–242. doi: 10.1038/clpt.2013.70