The cornerstone product for the regulatory affairs industry, this book is used as an essential training tool at many prominent healthcare organizations, a mandatory text in many university-level courses and the most popular reference tool in preparing for the RAC (US) Exam. The new edition has been updated to reflect the current regulatory requirements for the US Food and Drug Administration (FDA) and other state and federal agencies, and covers the full range of established regulatory requirements across product lines and throughout the product lifecycle. The 33 chapters are categorized into topic-specific sections, allowing you to quickly find the information you need. There are new chapters on Drug, Biologic and Device Regulatory Pathways; FDA Communications and Meetings; Patents and Exclusivity; and Veterinary Products. This product is a recommended reference tool in preparing for the RAC (US) Exam and is available in a variety of discounted reference packages.