FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.
The Third Edition of this highly successful publication:
Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketingIncludes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXELFocuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirementsProvides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) VExplains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions
Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that's broadly useful to both business and academia.
Publisher: Taylor & Francis Ltd
Number of pages: 400
Weight: 658 g
Dimensions: 229 x 152 x 20 mm
Edition: 3rd New edition
"This book covers the myriad of topics related to the development and marketing of all types of drugs and devices regulated by the U.S. Food and Drug Administration. The book discusses not only the relevant regulations, but also the administrative processes that sponsors must deal with in getting their products approved for marketing. ... This book covers many of the important issues in enough depth to answer basic questions related to the components of an IND (investigational new drug) and an NDA (new drug application), as well as IDE (investigational device exemption) and 510k applications. ... This book fulfills a unique need for those seeking a book for a course in drug and device development or for those in the industry who seek information outside of their area of expertise."
-Michael R. Jacobs, BS, PharmD, Temple University School of Pharmacy, in Doody's Book Reviews
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