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

chapter 2|36 pages

What Is an IND?

chapter 4|16 pages

Meeting with the FDA

chapter 5|42 pages

FDA Medical Device Regulation

chapter 6|20 pages

The Development of Orphan Drugs

chapter 14|18 pages