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- W2599954558 abstract "Pharmaceutical products for humans and animals may have toxic effects on human or animal reproductive and developmental processes. Various governmental agencies are charged with monitoring the safety of pharmaceuticals and biologics used to treat or prevent disease in humans and animals. Adverse event reporting systems and pharmacovigilance are important for monitoring the safety of medical products and in protecting public health. The US Food and Drug Administration (US FDA) is a regulatory, science-based federal agency responsible for protecting and promoting the public health through the monitoring and regulation of a number of items necessary for the health and well-being of consumers. This chapter will focus on the FDA's pharmacovigilance and surveillance activities as related to the regulation of marketed drugs and vaccines intended for use in humans, and drugs intended for use in animals. Examples of regulatory programs and issues specifically regarding potential reproductive and developmental toxicity of pharmaceutical products will be presented." @default.
- W2599954558 created "2017-04-07" @default.
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- W2599954558 date "2017-01-01" @default.
- W2599954558 modified "2023-09-26" @default.
- W2599954558 title "Postmarket Surveillance and Regulatory Considerations in Reproductive and Developmental Toxicology" @default.
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- W2599954558 doi "https://doi.org/10.1016/b978-0-12-804239-7.00008-1" @default.
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