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The FDA: A Spoonful of Safety Makes The Medicine Go Down

Unbiased Science

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FDA's Focus on Drug Safety and Efficacy

This chapter discusses the concepts of safety and efficacy in relation to drug approval by the FDA. It highlights the historical focus on drug safety and the transition to requiring drugs to be both safe and effective. The chapter also highlights the devastating effects of the drug Thalidomide and the role of Francis Kelsey in preventing its approval in the US.

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