Overview

This practical book provides toxicologists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology, Third Edition is an up-to-date guide to required safety assessment for the entire range of man-made marketed products. Individual chapters written by experts with extensive experience in the field address requirements not only for human pharmaceuticals and medical devices (for which there are available guidances), but for the full range of man-made products. New in this edition are three chapters addressing Safety Data Sheet Preparation, Regulatory Requirements for GMOs, and Regulatory Requirements for Tobacco and Marijuana. The major administrative divisions for regulatory agencies and their main responsibilities are also detailed, as are the basic filing documents the agencies require. Coverage includes food additives, dietary supplements, cosmetics, over-the-counter drugs, personal care and consumer products, agriculture and GMO products, industrial chemicals, air and drinking water regulations and the special cases of California’s Proposition 65, requirements for safety data sheets, and oversight regulations. Both US and international requirements are clearly presented and referenced. In one volume, those who have regulatory responsibility in companies, lawyers, educators, and those selling these materials in the marketplace can learn about regulatory requirements and how to meet them.

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9781498780827

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Author Information

Editor Shayne C. Gad, BS (Whittier College, Chemistry and Biology, 1971) and PhD in Pharmacology/ Toxicology (Texas, 1977), DABT, is the principal of Gad Consulting Services, a twenty-five-yearold consulting firm with nine employees and more than 500 clients (including 140 pharmaceutical companies in the US and 50 overseas). Prior to this, he served in director-level and above positions at Searle, Synergen, and Beckton Dickinson. He has published 50 books and more than 350 chapters, articles, and abstracts in the fields of toxicology, statistics, pharmacology, drug development, and safety assessment. He has more than 40 years of broad-based experience in toxicology, drug and device development, statistics, and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, and genotoxicology. Past president of the American College of Toxicology, the Roundtable of Toxicology Consultants, and three of SOT’s (Society of Toxicology) specialty sections. He has direct involvement in the preparation of Investigational New Drug applications (INDs, 115 successfully to date), New Drug Application (NDA), Product License Application (PLA), Abbreviated New Drug Application (ANDA), 501(k), Investigational Device Exemption (IDE), Common Technical Document (CTD), clinical data bases for phase 1 and 2 studies, and Premarket Approval Applications (PMAs). He has consulted for the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and National Institutes of Health (NIH), has trained reviewers, and has been an expert witness for the FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the last 29 years. Dr. Gad is also a retired Navy officer with more than 26 years in service.

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