Product Description

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 chapterhighlighting 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

Product Details

• Amazon Sales Rank: #80158 in Books
• Published on: 2008-08-11
• Original language: English
• Number of items: 1
• Binding: Hardcover
• 464 pages

Customer Reviews

Meet the FDA Head on
I used this book as part of my reference for a Couse in " Regulatory Affairs". for anybody who is interested in this field this is the most comprehensive review to date. I feel like the Author mapped the entire process from "Concept to Product" This is a very good book well researched, and a valuable resource to students and other people in the industry.

A must have for RA Professionals.
Even as a seasoned RA Professional, I found this book to be a invaluable resource. Simplifies a complex process!