Baby Steps Toward Better Pharmaceutical Care: Market Exclusivity Incentives to Research Pediatric Drug Uses Under the FDA Modernization and Accountability Act of 1997

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Baby Steps Toward Better Pharmaceutical Care: Market Exclusivity Incentives to Research Pediatric Drug Uses Under the FDA Modernization and Accountability Act of 1997

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Brown, Nathan A. en_US
dc.date.accessioned 2012-06-07T20:27:01Z
dc.date.issued 1998 en_US
dc.identifier.citation Baby Steps Toward Better Pharmaceutical Care: Market Exclusivity Incentives to Research Pediatric Drug Uses Under the FDA Modernization and Accountability Act of 1997 (1998 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852147
dc.description.abstract Part I of this paper reviews the perceived need for greater pediatric drug information and previous attempts at improving pediatric pharmaceutical treatment. Part II summarizes SOSA itself in relation to current patent and exclusivity provisions. Part III examines 505A in light of the current regulatory system and financial incentives, arguing that greater FDA discretion in implementing the provision and/or greater reliance on market forces would make SOSA more effective. Finally, Part IV argues that SOSA should be expanded beyond pediatric studies, to provide incentive for further drug studies for adult indications as well. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject pediatric drugs en
dc.subject Food and Drug Modernization Act of 1997 en
dc.title Baby Steps Toward Better Pharmaceutical Care: Market Exclusivity Incentives to Research Pediatric Drug Uses Under the FDA Modernization and Accountability Act of 1997 en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T20:27:01Z

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