David S. (Cubist Pharmaceuticals, Lexington, Massachusetts, USA) Mantus & Douglas J. Pisano 
FDA Regulatory Affairs 
A Guide for Prescription Drugs, Medical Devices, and Biologics

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, c GMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in