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dc.contributor.advisorHutt, Peter Bartonen_US
dc.contributor.authorPetrocelli, Gina M.en_US
dc.date.accessioned2012-06-07T18:08:21Z
dc.date.issued2002en_US
dc.identifier.citationACCUTANE: POST-APPROVAL DRUG REGULATION IN A RISK MANAGEMENT FRAMEWORK (2002 Third Year Paper)en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:8848242
dc.description.abstractThe acne drug Accutane lies at the center of a movement to expand post-approval controls on drug regulation in an effort to effectively manage drug risks. Accutane’s regulatory history tracks a trend towards the increasing emphasis in drug regulatory policy on post-marketing risk management. The Accutane experience illustrates the fundamental regulatory problems of drug safety, drug availability and individual autonomy driving this shift. Recent reform of Accutane regulation through the S.M.A.R.T. program both exemplifies the trend and suggests its limitations.en
dc.language.isoen_USen
dash.licenseLAAen_US
dc.subjectFood and Drug Lawen
dc.subjectAccutaneen
dc.subjectregulationen
dc.subjectdrug approvalen
dc.titleACCUTANE: POST-APPROVAL DRUG REGULATION IN A RISK MANAGEMENT FRAMEWORKen
dc.typePaper (for course/seminar/workshop)en_US
dc.date.available2012-06-07T18:08:21Z
dash.authorsorderedfalse


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