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 Affairs:

• provides a blueprint to the FDA and drug, biologic, and medical device development


• offers current, real-time information in a simple and concise format


• contains a chapter highlighting the new drug application (NDA) process


• discusses FDA inspection processes and enforcement options


• includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA

Three all-new chapters cover:

• clinical trial exemptions


• advisory committees


• provisions for fast track