From Pre-Market Approval to Post-Market Removal The Implications of Lifestyle Drugs for the Regulation of Herbal Remedies

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From Pre-Market Approval to Post-Market Removal The Implications of Lifestyle Drugs for the Regulation of Herbal Remedies

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Lin, Richard en_US
dc.date.accessioned 2012-12-07T15:15:40Z
dc.date.issued 2006 en_US
dc.identifier.citation From Pre-Market Approval to Post-Market Removal The Implications of Lifestyle Drugs for the Regulation of Herbal Remedies (2006 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:10015274
dc.description.abstract Both a popular lifestyle drug and an herbal remedy have recently been recalled due to concerns of safety. In the wake of these recalls, reforms were proposed to strengthen the FDA's post-marketing enforcement powers and resources. The emphasis on post-marketing enforcement is not surprising as the effectiveness of pre-market approval is reaching its limitations for the markets of both lifestyle drugs and herbal remedies. Moreover, consumer conceptions of both markets are conceptually converging, requiring the need for more consistent regulations. The FDCA provides sufficient post-marketing enforcement power over lifestyle drugs, but not for herbal remedies. An enhanced regulatory regime for herbal remedies would have the additional benefit of addressing the intellectual property issues that have plagued the full development of herbal remedies. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject herbal remedies en
dc.title From Pre-Market Approval to Post-Market Removal The Implications of Lifestyle Drugs for the Regulation of Herbal Remedies en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-12-07T15:15:40Z

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