Back to Fundamentals of US Regulatory Affairs, 10th Edition
This 10th edition of Fundamentals of US Regulatory Affairs presents information covering all lifecycle stages of regulated healthcare products. More than 50 authors contributed to the content, which is current through May 2017. New chapters in this edition include preclinical and clinical chapters on drugs and medical devices, biosimilars, and traceability and supply chain. The book is divided into seven sections:
I: General Information
III: Medical Devices
V: Other Product Classifications
VI: Inspection and Enforcement
General chapters cover such topics as the history of US regulation, FDA meetings, user fees, regulatory strategy, healthcare fraud and abuse and the new traceability chapter. The product-specific sections track development through postmarket compliance. Other products include topics like orphan drugs, foods, cosmetics, blood products and those derived from blood as well as tissue and cellular products.
Who Should Use This Publication?
Fundamentals of US Regulatory Affairs is designed for regulatory professionals working in the US market at all levels. 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 © 2017. Hardcover. 698 pages.