Oregon Law Review : Vol. 88 No. 4, p. 1189-1220 : These Statements Have Not Been Approved by the FDA: Improving the Postapproval Regulation of Prescription Drugs
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Date
2009
Authors
Page, Christopher R.
Journal Title
Journal ISSN
Volume Title
Publisher
University of Oregon Law School
Abstract
In light of the current regulatory climate, this Comment argues for
a new approach to the regulation of prescription drugs approved by
the FDA for general sale. The author proposes a reorganization of the
agency resulting in the creation of a division of the FDA that focuses
solely on actively making regulatory decisions regarding postapproval
pharmaceutical products. This new division should be granted the
power to effectively gather information and enforce regulations
against pharmaceutical companies without needing to consult with another agency or FDA division. The use of this power by a new
division would significantly ameliorate much of the public distrust
discussed previously.
Description
32 p.
Keywords
Pharmaceutical industry -- United States, United States. Food and Drug Administration, FDA