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- W4247278217 abstract "This chapter examines the regulations which establish how the safety of human pharmaceutical products is evaluated and established in the United States and the other major international markets. It reviews the history of this regulation and the current organizational structure of the Food and Drug Administration (FDA), along with the other quasigovernmental bodies that also influence the regulatory processes. The 1906 law was designed to control blatantly misbranded and/or adulterated foods and drugs and relied on post facto criminal charges for enforcement. The 1962 Drug Amendment made three major changes in the manner in which new drugs could be approved. The chapter presents the current structure and context of the regulations in the United States; and discusses the nonclinical safety assessment study designs. It addresses the broad special case of biotechnology-derived therapeutic products and environmental concerns associated with the production of pharmaceuticals." @default.
- W4247278217 created "2022-05-12" @default.
- W4247278217 date "2016-10-31" @default.
- W4247278217 modified "2023-09-23" @default.
- W4247278217 title "REGULATION OF HUMAN PHARMACEUTICAL SAFETY" @default.
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- W4247278217 doi "https://doi.org/10.1002/9781119097440.ch2" @default.
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