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Regulatory Focus™ > News Articles > 2019 > 7 > RAPS Publishes Updated Fundamentals of US Regulatory Affairs Book

RAPS Publishes Updated Fundamentals of US Regulatory Affairs Book

Posted 17 July 2019 | By Zachary Brousseau 

RAPS Publishes Updated Fundamentals of US Regulatory Affairs Book

RAPS has just published the updated, 11th edition of Fundamentals of US Regulatory Affairs, the most extensive regulatory affairs textbook available, covering US regulations for pharmaceuticals, medical devices, biologics and related healthcare products. First published 20 years ago, the book has become an important reference for regulatory professionals and others working with healthcare products regulated by the US Food and Drug Administration (FDA) and other US agencies.

“When RAPS first published Fundamentals of US Regulatory Affairs, Google was still in its infancy and finding important regulatory information was no easy task,” said RAPS Executive Director Paul Brooks. “Now, two decades later, the challenge has become information overload. The internet offers a wealth of information but being able to find and gather reliable and actionable information from multiple different sources is time- and labor-intensive. The reason this book is still so valuable is that it is the only reference that compiles such comprehensive US regulatory affairs knowledge in one place.”

Fundamentals of US Regulatory Affairs has undergone multiple revisions over its 11 editions, encompassing new regulations, new technologies and the constantly evolving practice of healthcare. Fundamentals of US Regulatory Affairs, 11th Edition includes more than 1,000 updates on regulations, legislation and agency guidances, and all information is current as of April 2019.

This edition includes 39 chapters by 54 expert authors, as well as an extensive matrix of regulations across product lines that has been completely revamped. New in this edition are two separate indexes—one on laws and guidances and one organized by subject matter, a new chapter on master protocol and comprehensively updated chapters on pediatrics, traceability and supply chain, and FDA user fees.

The book is useful to regulatory professionals at all job levels who work with healthcare products subject to US regulations, students in regulatory affairs degree programs, those studying for a Regulatory Affairs Certification (RAC) exam or anyone who needs authoritative information about US regulations and processes.

Fundamentals of US Regulatory Affairs, 11th Edition is available now in hardcover or e-book formats from the RAPS store.

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