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15 - Regulation of healthcare technologies

Published online by Cambridge University Press:  05 June 2012

Rebecca Richards-Kortum
Affiliation:
Rice University, Houston
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Publisher: Cambridge University Press
Print publication year: 2009

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References

Merrill, RA. Regulation of drugs and devices: an evolution. Health Affairs. 1994 May 1, 1994; 13(3): 47–69.CrossRefGoogle Scholar
,Administration USFaD. Evidence on the Safety and Effectiveness of Ephedra: Implications for Regulation. February 28, 2003.
Specter, M. Miracle in a bottle. The New Yorker. 2004 February, 2004: 64–75.Google Scholar
Medicine, NCfCaA. Reducing ephedra-related risks. 2003 [refd June 8, 2007]; Available from: http://nccam.nih.gov/health/alerts/ephedra/022803.htm
Rados, C. Ephedra ban: no shortage of reasons. FDA Consumer. 2004 March–April 2004.Google ScholarPubMed
,Administration USFaD. Innovation or stagnation?: Challenge and opportunity on the critcal path to new medical products. In: Services USDoHaH, ed. 2004.
,Administration USDoFaD. History of the FDA. [refd 2007 June 8, 2007]; Available from: http://www.fda.gov/oc/history/historyoffda/
,Administration USFaD. A brief history of the Center for Drug Evaluation and Research. November 1997 [refd 2007 June 8, 2007]; Available from: http://www.fda.gov/cder/about/history/Histext.htm.
,Administration USFaD. Thalidomide: important patient information. July 7, 2005 [refd 2007 June 9, 2007]; Available from: http://www.fda.goc/cder/news/thalidomide.htm
Morris, CA, Avorn, J. Internet marketing of herbal products. JAMA. 2003 September 17, 2003; 290(11): 1505–9.CrossRefGoogle ScholarPubMed
Wholey, MH, Haller, JD. An introduction to the Food and Drug Administration and how it evaluates new devices: establishing safety and efficacy. Cardiovascular and Interventional Radiology. 1995 Mar–Apr 1995; 18(2): 72–6.CrossRefGoogle ScholarPubMed
Pritchard, WF, Carey, RF. U.S. Food and Drug Administration and regulation of medical devices in radiology. Radiology. 1997 October 1, 1997; 205(1): 27–36.CrossRefGoogle Scholar
,Administration USFaD. FDA regulatory actions for the CoX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs): questions and answers. April 7, 2005 [refd 2007 June 9, 2007]; Available from: http://www.fda.gov/cder/drug/infopage/COX2/COX2qa.htm.
,Administration USFaD. COX-2 selective (includes Bextra, Celebrex, and Vioxx) and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). July 18, 2005 [refd 2007 June 9, 2007]; Available from: http://www.fda. gov/cder/drug/infopage/COX2/default.htm
,Administration USDoFaD. FDA public health advisory: FDA announces important changes and additional warning for COX-2 and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). April 7, 2005 [refd 2007 June 9, 2007]; Available from: http://www.fda.gov/cder/drug/advisory/COX2.htm
,Administration USFaD. FDA News: FDA announces series of changes to the class of marketed non-steroidal anti-inflammatory drugs (NSAIDs). April 7, 2005 [refd June 9, 2007]; Available from: http://www.fda.gov/bbs/topics/news/2005/NEW01171.html
Krumholz, HM, Ross, JS, Presler, AH, Egilman, DS. What have we learnt from Vioxx?BMJ. 2007 January 20, 2007; 334(7585): 120–3.CrossRefGoogle ScholarPubMed
Zarraga, IGE, Schwarz, ER. Coxibs and heart disease: what we have learned and what else we need to know. Journal of the American College of Cardiology. 2007 January 2, 2007; 49(1): 1–14.CrossRefGoogle ScholarPubMed
Bogdanich, W and Hooker, J. From China to Panama, a trail of poisoned medicine. The New York Times, May 6, 2007.Google Scholar

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