Rockville, MD, USA (PRWEB) July 02, 2013
The Regulatory Affairs Specialists Society (RAPS) has published the updated, eighth edition of its crucial regulatory reference book, Fundamentals of US Regulatory Affairs. The book provides extensive data on existing regulatory needs from the US Meals and Drug Administration (FDA), and other state and federal agencies.

Fundamentals of US Regulatory Affairs, Eighth Edition includes updated regulatory information pertaining to pharmaceuticals, health-related devices, biologics and other healthcare items intended for the US market place. New content for this edition involves coverage of the Meals 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 FDAs Center for Drug Evaluation and Study, and is publicly accessible online.

This book is an outstanding overview of the drug, biologic and device regulatory pathways and needs. It is thorough and clearly written, mentioned Edward Tabor, MD, vice president, regulatory affairs North America, Fresenius Kabi, and a member of RAPS board of directors. Not only is it beneficial for any individual who wants to learn about the regulatory method it also gives a prepared reference for skilled regulatory experts.

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

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

About RAPS

The Regulatory Affairs Specialists Society (RAPS) is the largest worldwide organization of and for these involved with the regulation of healthcare and associated items, such as health-related devices, pharmaceuticals, biologics and nutritional merchandise. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively assistance the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS provides education and instruction, skilled standards, publications, research, understanding sharing, networking, profession development possibilities and other worthwhile resources, such as Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide. RAPS.org