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The FDA draws specific attention because of the palpable effects of its rulings in the lives of all citizens. Specifically, the requirements for the pre-market approval of new drugs have been criticized for being too cumbersome. This paper will attempt to draw a compromise between the observed problem of overregulation in that area and the still important policies underlying the federal Food, Drug, and Cosmetic Act (FDCA). It will call for the elimination of the efficacy requirement for new drug applications (NDA) as a way to reduce the costs of developing new drugs, while maintaining the safely requirement in order to ensure the public health...
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