Posted 16 August 2017
By Zachary Brousseau
RAPS has published the updated, 10th edition of Fundamentals of US Regulatory Affairs, the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices, biologics and other healthcare products intended for the US market. The book is an essential reference for anyone responsible for products that must comply with regulations from the US Food and Drug Administration (FDA) and other relevant US agencies.
The first edition of US Fundamentals was introduced two decades ago and has undergone regular revisions over the years, reflecting changing regulations and new technologies. Fundamentals of US Regulatory Affairs, 10th Edition has been completely updated with information that is current as of May 2017. Notable changes from the previous edition include more detail in areas such as preclinical trials and Good Laboratory Practices, and clinical trials and Good Clinical Practices. New chapters have been added on traceability and supply chain, and biosimilars. In all, the book is comprised of 44 chapters by 53 regulatory experts.
In addition, for the first time, RAPS has also published two sector-specific US fundamentals books, Fundamentals of US Medical Device Regulations and Fundamentals of US Pharmaceutical & Biologics Regulations. Each one presents the same content published in the 10th edition, but only that which is related to either medical devices or pharmaceuticals and biologics, respectively. This allows those who work exclusively in one sector or the other to get all the information that is pertinent to them without additional content that may not be.
The list price for the full 10th edition is $395, while RAPS members get $100 off that price. Each of the sector-specific books is available for $225 list, and $175 for members. All are available in both print and e-book versions.
Since its introduction, US Fundamentals has sold more than 30,000 copies. It is relied upon by regulatory and legal professionals, professors, students, career-changers and FDA staffers as a valued reference, academic textbook and Regulatory Affairs Certification (RAC) study tool.
For more information or to order any of the fundamentals books, visit RAPS.org/fundamentals.