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This publication is derived from the 11th edition of Fundamentals of US Regulatory Affairs and focuses on US drug and biologics’ legislation and regulations. It also reviews the history of US food, drug and cosmetic laws and the development of the regulatory environment. Chapters included in this discuss:
Specific to biologics are chapters on
Who Should Use This Publication?
Fundamentals of US Regulatory Affairs is designed for regulatory professionals working on products for the US market at all levels with a focus on pharmaceuticals and biologics. Whether you’re new to the profession or a veteran, you’ll find valuable information in the carefully curated pages.
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Published by RAPS © 2019. E-Book. 330 pages.