No Humans Have Been Injured in the Testing of this Drug: The New Animal Efficacy Rule

DSpace/Manakin Repository

No Humans Have Been Injured in the Testing of this Drug: The New Animal Efficacy Rule

Show simple item record

dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Campbell, Carrie en_US
dc.date.accessioned 2012-06-15T20:56:13Z
dc.date.issued 2004 en_US
dc.identifier.citation No Humans Have Been Injured in the Testing of this Drug: The New Animal Efficacy Rule (2004 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8889487
dc.description.abstract This paper examines the “Animal Efficacy Rule,†a regulation that provides for the approval of products by the FDA when efficacy testing on humans is ethically impossible. It gives a summary of the history of the enactment of this regulation and outlines its structure and major features. Next, the regulation is analyzed in light of statutory authority, ethics, and practicality. Finally the approval of pyridostigmine bromide under the Animal Efficacy Rule is evaluated in light of these concerns to determine whether the rule is acting as intended, illustrating remaining problems in implementation. The article concludes that while the Animal Efficacy Rule meets ethical requirements and is capable of being implemented given careful supervision, the FDA does not have statutory authority to make such regulation and thus a legislative solution is preferable. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject ethics en
dc.subject drug testing en
dc.subject animal efficacy rule en
dc.title No Humans Have Been Injured in the Testing of this Drug: The New Animal Efficacy Rule en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-15T20:56:13Z

Files in this item

Files Size Format View
Campbell.pdf 178.8Kb PDF View/Open
Campbell.rtf 120.0Kb RTF file View/Open
Campbell.html 89.19Kb HTML View/Open

This item appears in the following Collection(s)

Show simple item record

 
 

Search DASH


Advanced Search
 
 

Submitters