Protecting the Ignorant, the Unthinking and the Credulous: Are the FDA's Efforts to Accelerate the Drug Approval Process Compromising Public Safety?

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Protecting the Ignorant, the Unthinking and the Credulous: Are the FDA's Efforts to Accelerate the Drug Approval Process Compromising Public Safety?

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Title: Protecting the Ignorant, the Unthinking and the Credulous: Are the FDA's Efforts to Accelerate the Drug Approval Process Compromising Public Safety?
Author: Katz, Gail
Citation: Protecting the Ignorant, the Unthinking and the Credulous: Are the FDA's Efforts to Accelerate the Drug Approval Process Compromising Public Safety? (2000 Third Year Paper)
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Abstract: Recently, five approved prescription drugs were recalled in a one-year period after the Food and Drug Administration (FDA or the agency) deemed them to be too unsafe for patient use. Notorious among them was fenfluramine (Pondimin), the "fen" half of "fen-phen," a drug used to promote weight loss in patients. The list also includes Seldane, a popular antihistamine as well as Redux, Posicor, and the pain medication Duract. All had side effects not detected in clinical trials. This unusually high rate of withdrawals in such a short period of time sparked the most recent round of debate over the ever-controversial topic of the FDA drug approval process.
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Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:8965591

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