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Drug Regulation in the United States

Published online by Cambridge University Press:  10 March 2009

Peter Barton Hutt
Peter Barton Hutt
Affiliation:
Covington & Burling, U.S.A.
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Extract

Drug regulation in the United States has been the subject of extensive public literature and has been studied more thoroughly than any other aspect of American governmental regulation. Yet it remains mired in criticism and debate that, over the years, have threatened not only the existing regulatory system but also the stability of the American drug industry itself. This article summarizes the history of drug regulation in the United States, discusses the basic structure of the American regulatory system as it exists today, and relates some of the more important controversies that continue to surround this subject.

Information

Type
Special Section: The Evaluation of Drugs: An International Perspective
Information
International Journal of Technology Assessment in Health Care , Volume 2 , Issue 4 , October 1986 , pp. 619 - 628
Copyright
Copyright © Cambridge University Press 1986

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References

REFERENCES

1.Flannery, E. J., & Hutt, P. B.Balancing competition and patent protection in the drug industry: the drug price competition and patent term restoration act of 1984, Food Drug Cosmetic Law Journal, 1985, 40, 269–309.Google Scholar
2.Hutt, P. B., Investigations and reports respecting FDA regulation of new drugs, Clinical Pharmacology and Therapeutics, 1983, 33, 537 (Part I) and 1983, 33, 674 (Part II).CrossRefGoogle ScholarPubMed
3.Hutt, P. B., A legal framework for future decisions on transferring drugs from prescription to nonprescription status, Food Drug Cosmetic Law Journal, 1982, 37, 427–40.Google Scholar
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