RAPS Releases New Edition of Essential US Regulatory Affairs Reference Book

The Regulatory Affairs Professionals Society (RAPS) has published the updated, eighth edition of its essential regulatory reference book, Fundamentals of US Regulatory Affairs. The book provides extensive information on current regulatory requirements from FDA, and other state and federal agencies.

Fundamentals of US Regulatory Affairs, Eighth Edition includes updated regulatory information pertaining to pharmaceuticals, medical devices, biologics and other healthcare products intended for the US market. New content for this edition includes coverage of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, and new chapters on pharmacovigilance, medical foods, crisis management, health technology assessment, and companion diagnostics. A chapter on Prescription Drug Product Submissions was revised by reviewers from FDA’s Center for Drug Evaluation and Research, and is publicly available online.

“This book is an outstanding overview of the drug, biologic and device regulatory pathways and requirements. It is thorough and clearly written,” said Edward Tabor, MD, vice president, regulatory affairs North America, Fresenius Kabi, and a member of RAPS’ board of directors. “Not only is it useful for anyone who wants to learn about the regulatory process; it also provides a ready reference for experienced regulatory professionals.”

In addition to being useful to professionals new to US regulatory affairs or as handy reference, many professionals preparing for the US Regulatory Affairs Certification (RAC) exam cite Fundamentals as an indispensable RAC study tool. It also has been used as a training resource at many healthcare organizations and is a mandatory text for university-level courses.

Fundamentals of US Regulatory Affairs, Eighth Edition is available both in print and as an e-book for $249.95 with free shipping for RAPS members or $309.95, plus shipping, for nonmembers.