Back to Fundamentals of US Regulatory Affairs, Ninth Edition
Knowledge is the driving force of success in regulatory. Whether you are navigating the world of the US Food and Drug Administration or working in pharmaceuticals, biotech or medical devices, you need access to the most up-to-date information in your field.
With new and updated content on everything from the history of food, drug and cosmetic laws to crisis management and FDA inspection and enforcement, this all-in-one reference book has you covered.
The ninth edition features the experience and analysis of 49 authors in 41 chapters, and includes an updated matrix listing all pertinent laws and regulations as well as numerous tables, figures and other visual aids. It also includes three new chapters covering essentials such as regulatory strategy, stem cell technology and user fees. This new and innovative edition is the definitive guide to all US regulatory matters. RAPS and its expert authors have gathered all the information for you to continue your success and regulatory excellence.
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.
Get the e-book version when you select the bundled option and save almost 40%. The e-book is a secure PDF, compatible with most tablets. You may need to download an app for your specific device.
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Published by RAPS © 2015. Hardcover. 604 pages.