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

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

DSpace/Manakin Repository

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

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. 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.	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