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Fundamentals of US Regulatory Affairs, 11th Edition (2022 Update)

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Fundamentals of US Regulatory Affairs, 11th Edition (2022 Update)

Table of Contents

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Product Description

This 11th 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 April 2019. The content in this edition is more detailed than in the past and includes a new chapter on the master protocol. The book is divided into eight sections:
 
  1. General Information
  2. Drugs
  3. Medical Devices
  4. Biologics
  5. Foods
  6. Other Product Classifications
  7. Inspection and Enforcement
  8. Resources

What's New in the updated 2022 edition?

The 2022 update includes completely revised medical device and in vitro diagnostic (IVD) chapters from Fundamentals of Medical Device Regulations, Fifth Edition. In addition, global experts have provided related content on combination products; regulatory strategy; advertising and promotion; enforcement and competent authorities; FDA communications, meetings, and user fees; current good manufacturing practices; quality system design; preclinical testing; clinical evaluation; and clinical investigations. 

Bonus: Free E-book with Every Purchase

Receive a free e-copy of the Fundamentals of US Regulatory Affairs, 11th Edition with every purchase of the printed version. Note: The Fundamentals of US Regulatory Affairs, 11th Edition e-book is no longer available for purchase separately.

Who should buy this book?

Fundamentals of US Regulatory Affairs is designed for regulatory professionals working on products for the US market at all levels and is a useful tool for those planning to sit for the RAC US, drug or medical device exam. Whether you’re new to the profession or a veteran, you’ll find valuable information in the carefully curated pages.

Free RAPS Member Resource

Check out RAPS Regipedia - a growing collection of more than 2,300 regulatory terms, definitions and acronyms developed exclusively for RAPS members.

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Published by RAPS © 2019. Hardcover. 752 pages. ISBN:978-1-947493-33-9.
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