Regulatory Toxicology, Third Edition

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.

Introduction. Human Pharmaceutical Products. Animal Health Products. Regulatory Aspects and Strategy in Medical Device and Bio Materials Safety Evaluation. Food Additives and Nutrition Supplements. Regulations Affecting Cosmetic and Over-the-counter Drug Products. OTC Drugs and Nutraceuticals. Consumer Products: Non-personal Care Products. Agricultural Chemicals: Regulation, Risk Assessment, and Risk Management. Industrial Chemicals: International Regulation of New and Existing Chemicals (REACH, the New Toxic Substances Control Act and Similar Worldwide Chemical Control Laws). Industrial Chemicals: Hazard Communication, Exposure Limits, Labeling and Other Workplace and Transportation Requirements under OSHA, DOT, and Similar Authorities Around the World. Federal Air and Water Regulations: SDWA, CAA, HAPS and Ozone Regulation. Understanding the Safe Drinking Water and Toxic Enforcement Act of 1986 (California’s Proposition 65). Safety Data Sheets (SDSs). GMOs (Internationally). Tobacco and Marijuana. Oversight regulations.