What About the Children? - FDA's Response to Pediatric Drug Testing

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What About the Children? - FDA's Response to Pediatric Drug Testing

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Doerner, Kristina M. en_US
dc.date.accessioned 2012-06-15T20:29:11Z
dc.date.issued 2003 en_US
dc.identifier.citation What About the Children? - FDA's Response to Pediatric Drug Testing (2003 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8889476
dc.description.abstract The Federal Food and Drug Administration (FDA) has played a critical role in the protection of human subjects in research. Most recently, FDA enacted an interim final rule regarding protection of children in clinical investigations. FDA’s interim rule represents its most current policy on human subject protection. Current events illuminate FDA’s policies and how FDA has chosen to respond to debates over pediatric drug testing. This paper will provide a brief history of FDA’s participation in human subject protection. This paper will then focus on FDA’s policies for pediatric research, its interim rule, and how the interim rule relates to current events. Finally, this paper will make a comment about how FDA balances its competing duties of protecting the public but also of promoting research. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject human subject protection; en
dc.subject pediatric drug testing; en
dc.subject children in clinical trials en
dc.title What About the Children? - FDA's Response to Pediatric Drug Testing en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-15T20:29:11Z

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