USA – 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…