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FDA Regulatory Affairs
A Guide for Prescription Drugs, Medical Devices, and Biologics
Overview
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.
Second Edition Focus
The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements.
Writing Style
Written in ...
