FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

1st Edition

Douglas J. Pisano, David Mantus

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CRC Press
Published December 23, 2003
Reference - 360 Pages
ISBN 9780429204579 - CAT# KE88699

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Summary

Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of regulations that can be hard to navigate. Not only are existing regulations constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field creates new issues that need to be addressed b

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