What About the Children? - FDA's Response to Pediatric Drug Testing
Doerner, Kristina M.
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CitationWhat About the Children? - FDA's Response to Pediatric Drug Testing (2003 Third Year Paper)
AbstractThe 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. FDAâ€™s interim rule represents its most current policy on human subject protection. Current events illuminate FDAâ€™s policies and how FDA has chosen to respond to debates over pediatric drug testing. This paper will provide a brief history of FDAâ€™s participation in human subject protection. This paper will then focus on FDAâ€™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.
Citable link to this pagehttp://nrs.harvard.edu/urn-3:HUL.InstRepos:8889476
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