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New Drug Approval: FDA Needs to Enhance its Oversight of Drugs Approved on the Basis of Surrogate Endpoints
Marcia Crosse (au)
Before approving a drug, the FDA assesses a drug's effectiveness. This assessment may be based on evidence showing that a drug has a positive impact on a surrogate endpoint (SE) -- a laboratory measure, such as blood pressure -- instead of more direct clinical evidence, like preventing strokes. After approval, FDA requires a drug sponsor to further study the drug. There have been concerns about FDA's reliance on SE and its oversight of post-marketing studies (PS). This report provides info. on: (1) all drug applications approved based on SE in FDA's accelerated approval process; (2) a subset of applications for potentially innovative drugs approved based on SE under FDA's traditional process; and (3) FDA's oversight of PS. Illustrations.
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