Examines 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. The "Second Edition" focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

"FDA Regulatory...

This book examines the laws relating to the practice of pharmacy and the regulation and control of drugs. Written by a practicing pharmacist in clear, accessible, contemporary prose, this user-friendly text deals largely with federal law. Case studies and review questions make for easy reading and aid in comprehension. Essentials of Pharmacy Law will be extremely useful to senior pharmacy students preparing for the Multi-State Jurisprudence Exam (MJPE). It also serves as a valuable reference for pharmacy students, practicing pharmacists seeking licensure by reciprocity and/or preparing for...

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.

The Third Edition of this highly successful publication:

• Examines the harmonization...