Fundamentals of US Regulatory Affairs, 11th Edition (Hardcover)

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Fundamentals of US Regulatory Affairs, 11th Edition (Hardcover)

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>> Author Acknowledgments

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

General chapters cover such topics as the history of US regulation, FDA meetings, user fees, regulatory strategy, healthcare fraud and abuse and traceability. Specific sections discuss product development through postmarket compliance. Other chapters address orphan drugs, foods, 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 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.

Special Offer

Also available as an e-book

To purchase both the hardcover and e-book versions, add either item to your cart, then select the other format listed under "Optionally select from the following items:" at a discounted rate on the next screen. Discount is only available when purchasing both versions in the same transaction.

Sector-Specific Options

Interested in US regulatory affairs but want to concentrate on a particular product sector? RAPS offers the option to purchase the sector-specific content of this book relating to either medical devices or pharmaceuticals individually in e-book format. 

*Both the hardcover and e-book versions of Fundamentals of US Regulatory Affairs, 11th Edition contain the content available in the sector-specific e-books.

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

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