£125.68

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£126 today · usual range £105–£130 · best ever £105

CRC Press FDA Regulatory Affairs: Third Edition

Amazon

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Last 78 days · 78 data points (no recent data)

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£130.01 £102.00 £108.11 £114.22 £120.34 £126.45 £132.56 25 July 2026 13 August 2026 01 September 2026 20 September 2026 10 October 2026
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31 black & white illustrations, 25 black

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Price distribution over 78 days • 6 price levels

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43 days 2 days 2 days 25 days · current 4 days 2 days 0 11 22 32 43 £105 £116 £125 £126 £128 £130 Days at Price

Price Analysis

Most common price: £105 (43 days, 55.1%)

Price range: £105 - £130

Price levels: 6 different prices over 78 days

Description
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 marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides 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) V Explains 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.

Product Specifications
Brand
CRC Press
Model
31 black & white illustrations, 25 black
Format
hardcover
ASIN
1841849197
Category
Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain
Amazon UK
Release Date
29 January 2014
Listed Since
27 June 2011

Barcode

No barcode data available

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