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pages 151-171
Country Report U.S.A.
1
Washington and Lee University School of Law, Lexington, USA
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Publication type: Book Chapter
Publication date: 2010-01-01
Abstract
This paper examines the influence of the European Good Clinical Practices Guidelines, Directive 2001/20/EC of 4 April 2001 on the law and legal discussion of the United States. It begins with a description of the U.S. approach to the regulation of clinical trials and new drug approval. It next discusses the U.S. participation in the process of pharmaceutical regulation harmonization and U.S. recognition of foreign drug trials for supporting U.S. new drug applications. It then compares contemporary U.S. drug regulation with the requirements of Directive 2001/20/EC. Finally, it briefly reviews recent controversies in drug regulation in the U.S.
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TY - GENERIC
DO - 10.1007/978-3-642-13177-6_9
UR - https://doi.org/10.1007/978-3-642-13177-6_9
TI - Country Report U.S.A.
T2 - Trust in Biobanking
AU - Jost, Timothy Stoltzfus
PY - 2010
DA - 2010/01/01
PB - Springer Nature
SP - 151-171
SN - 1617-1497
ER -
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@incollection{2010_Jost,
author = {Timothy Stoltzfus Jost},
title = {Country Report U.S.A.},
publisher = {Springer Nature},
year = {2010},
pages = {151--171},
month = {jan}
}