RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

The RAPS store will be under maintenance Saturday, 13 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > New Fundamentals of US Regulatory Affairs Book Now Available

New Fundamentals of US Regulatory Affairs Book Now Available

Posted 10 August 2015 | By Zachary Brousseau 

New Fundamentals of US Regulatory Affairs Book Now Available

RAPS has just published the updated, ninth edition of Fundamentals of US Regulatory Affairs, the book that has become one of the most essential references for regulatory professionals working with healthcare products for the US market. The new edition is now available in a print, hardcover edition or as an e-book. RAPS currently is offering free shipping for the book and for all orders from the RAPS Store through 31 August.

Fundamentals of US Regulatory Affairs, Ninth Edition has been completely updated, and includes extensive, current regulatory information for pharmaceuticals, medical devices and biologics. The book covers regulatory topics ranging from the history of food, drug and cosmetic laws to crisis management and US Food and Drug Administration (FDA) inspection and enforcement.

“At more than 600 pages, this is the biggest edition of Fundamentals of US Regulatory Affairs we have ever done,” said the book’s senior editor, Pamela Jones. “It’s grown a lot over the years, and this edition includes 41 chapters written by 49 expert authors.”

The ninth edition includes a useful matrix listing all pertinent laws and regulations, and three new chapters: Regulatory Strategy, Regenerative Medicines (stem cell therapies), and FDA User Fees. This will be the first edition to be published as a hardcover, a feature that has been a popular request.

Considered the definitive guide to US regulatory matters, US Fundamentals is estimated to have sold more than 30,000 copies since its introduction nearly two decades ago. It is used throughout the life sciences world by regulatory professionals, university professors and students, career-changers and FDA staffers alike as a handy reference, academic textbook or Regulatory Affairs Certification (RAC) study tool.

For more information about the book or to place an order, visit RAPS.org/fundamentals.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.