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FDA Regulatory Affairs : A Guide for Prescription Drugs, Medical Devices, and Biologics by Douglas J. Pisano; David S. Mantus is a scholarly article available to read on EtoBox.

What is FDA Regulatory Affairs : A Guide for Prescription Drugs, Medical Devices, and Biologics about?

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

Author

Douglas J. Pisano; David S. Mantus

Publisher

CRC Press LLC

Published

2008

Language

EN

ISBN

9786611801298