ACCUTANE: POST-APPROVAL DRUG REGULATION IN A RISK MANAGEMENT FRAMEWORK

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ACCUTANE: POST-APPROVAL DRUG REGULATION IN A RISK MANAGEMENT FRAMEWORK

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Petrocelli, Gina M. en_US
dc.date.accessioned 2012-06-07T18:08:21Z
dc.date.issued 2002 en_US
dc.identifier.citation ACCUTANE: POST-APPROVAL DRUG REGULATION IN A RISK MANAGEMENT FRAMEWORK (2002 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8848242
dc.description.abstract The 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.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject Accutane en
dc.subject regulation en
dc.subject drug approval en
dc.title ACCUTANE: POST-APPROVAL DRUG REGULATION IN A RISK MANAGEMENT FRAMEWORK en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T18:08:21Z

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