This third edition of FDA Regulatory Affairsexamines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. Focusing on new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements this is a key title for anyone involved in pharmaceutical regulation. Jargon-free and drawing information from a wide range of resources, this book demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.