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RISK: Health, Safety & Environment

Abstract

The FDA seems to acknowledge that sometimes different standards of proof for assessing drug efficacy should be used. Dr. Mendeloff thus proposes a methodology that might illuminate the FDA's decision-making and help better to assess its decisions.

Repository Citation

John M. Mendeloff, Decision Analysis and FDA Drug Review: A Proposal for Shadow Advisory Committees, 6 RISK 203 (1995).

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