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FDA Regulatory Affairs: A Guide for Prescription Drugs, by David Mantus,Douglas J. Pisano

By David Mantus,Douglas J. Pisano

This publication covers the regulatory procedure for purchasing prescribed drugs, biologics, and clinical units authorized. It examines the pertinent features of the Federal nutrients, Drug and beauty Act because it applies to human drug and equipment improvement, examine, production, and advertising. issues contain: the drug approval method, present strong production Practices, strong scientific Practices, caliber approach Compliance and the corresponding documentation requisites, and FDA inspection strategies and enforcement ideas. even supposing many references exist in this topic, this one is written in a basic prose kind that makes it valuable to either scholars and professionals.

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