Regulation of Safety, Efficacy, and Quality
作者： M.K. Olson
DOI: 10.1016/B978-0-12-375678-7.01202-5
关键词:
摘要: This article focuses on market access regulations for innovative, brand name drugs. Market regulation drugs is designed to ensure their safety, efficacy, and quality. The begins with an introduction the scope, rationale, objectives of key cost trade-offs associated these are characterized. An overview important pharmaceutical regulatory legislation affecting then presented. highlights motivating forces change features new regulation. EMA discussed in later section. next section describes evolving evidence about reflected policy. final provides a discussion recent reforms Food Drug Administration offers some concluding thoughts state current
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