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WASHINGTON, Sept. 5, 2017 /PRNewswire/ -- The Regulatory Affairs Professionals Society (RAPS) has just published the updated 10th tenth edition of its popular text, 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 comprised of 44 chapters by 53 regulatory experts.
Among the book's authors are Jim DiBiasi, Cindy DiBiasi and Kell Cannon of 3D Communications who authored two chapters in the book: Chapter 4: FDA Communications and Meetings, and Chapter 5: Preparing for FDA Advisory Committee Meetings. Fundamentals of US Regulatory Affairs covers US regulatory requirements across healthcare product lines, including pharmaceuticals, medical devices, biologics, and other product classifications.
"Fundamentals of US Regulatory Affairs is a 'must-have' for every regulatory professional," said Jim DiBiasi, partner at 3D Communications. "The chapters authored by 3D Communications provide insightful and practical tips for pharmaceutical, biotech, and device companies that are preparing to interact with the FDA."
The tenth edition of US Fundamentals has been updated to address current regulatory requirements from the Food and Drug Administration (FDA). This edition includes more details on pre-clinical and clinical trials and Good Clinical Practices, breaking these subjects down by product lines. It also includes new chapters on Biosimilars and supply chain.
"RAPS published the first edition of Fundamentals of US Regulatory Affairs two decades ago, and much has changed since then," said RAPS Executive Director Paul Brooks. "Over the years, this is the book that has been relied upon as the definitive resource on US regulations and regulatory affairs. This latest edition is no exception. It is a must-have for anyone who works with regulated products for the US market."
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. Since its introduction, it has sold more than 30,000 copies. US Fundamentals 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.
The list price for the full 10th edition is $395, while RAPS members get $100 reduction off that price. It is available in both print and e-book versions. For more information or to order Fundamentals of US Regulatory Affairs, visit RAPS.org/fundamentals.
About 3D Communications3D Communications is a strategic communications firm that works with top executives and their teams across scientific, healthcare, technology, education, financial, and business sectors to develop and deliver successful messages and presentations. For more information, visit www.3Dcommunications.us 3D has also written The FDA Clinical Submission Survival Manual. ©3D Communications (2010), and The FDA Advisory Committee Survival Manual: A Step-by-Step Guild to Preparing for a Successful Meeting. ©3D Communications (2008). Available at: www.3dcommunications.us/FDAsurvivalguide.html.
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