Hutt, Peter BartonGuerra, Marcelo2012-12-072004The FDA’s Role in the Development of Bioterrorist Countermeasures (2004 Third Year Paper)http://nrs.harvard.edu/urn-3:HUL.InstRepos:10015278As the agency that approves drug products used to treat bioterrorist diseases, the FDA plays a significant role in the domestic preparation against a bioterrorist attack. The changes that occurred at the agency in response the AIDS and cancer crises of the 1980’s have served as a blueprint for the changes made in response to the terrorist threat. These changes, often desirable but sometimes not, push even further the agency’s role as a collaborator in drug development. The paper investigates the threat of a biological weapon attack and the changes to the drug approval process that this threat has prompted.en-USFood and Drug LawbioterrorismPaper (for course/seminar/workshop)2012-12-07