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