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CHAPTER 4 The Theory of Drug Safety — Pharmacovigilance

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Why does a biopharmaceutical company need a drug safety group? How is a drug safety group constituted? What is the mission of such a drug safety group? A brief history of the US FDA’s safety duties and functions. The FDA’s mission. Pressures on the corporate safety department and the FDA. An overview of the safety functions of government agencies outside the United States.

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

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