Regulatory Toxicology, Third Edition (3^rd Ed.)

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.

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.

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.