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- W4312111655 abstract "The safety of pharmaceutical agents, medical devices, and food additives are the toxicology issues of the most obvious and longest-standing concern to the public. 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 the three major legislative acts covering pharmaceuticals: Pure Food and Drug Act; Food, Drug, and Cosmetic Act; and The Pediatric Research Equity Act. Federal regulation of the safety of drugs has had three major objectives: requiring testing to establish safety and efficacy; establishing guidelines as to which tests are required and how they are designed; and promulgating requirements of data recording and reporting. The agency formally charged with overseeing the safety of drugs in the United States is the Food and Drug Administration." @default.
- W4312111655 created "2023-01-04" @default.
- W4312111655 date "2022-12-23" @default.
- W4312111655 modified "2023-10-02" @default.
- W4312111655 title "REGULATION OF HUMAN PHARMACEUTICAL SAFETY: ROUTES TO HUMAN USE AND MARKET" @default.
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- W4312111655 doi "https://doi.org/10.1002/9781119755883.ch2" @default.
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