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

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

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