Reform of Drug Regulation — Beyond an Independent Drug-Safety Board
- 12 January 2006
- journal article
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 354 (2) , 194-201
- https://doi.org/10.1056/nejmsb053432
Abstract
The authors argue that extensive reform of the system of drug regulation in the United States is needed to improve drug safety. In order to develop a more comprehensive system that is not so narrowly focused on testing of drugs before marketing, the authors propose a new federal authority for drug regulation, to be made up of three independent centers: a Center for New Drug Approval, a Center for Post-marketing Studies, and a Center for Drug Information.Keywords
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