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CRC Press FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

Name: FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
Brand: CRC Press

Pharmacy - Dispensing

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Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval. FDA Regulatory Affairs: provides a blueprint to the FDA and drug, biologic, and medical device development offers current, real-time information in a simple and concise format contains a chapter highlighting the new drug application (NDA) process discusses FDA inspection processes and enforcement options includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA Three all-new chapters cover: clinical trial exemptions advisory committees provisions for fast track

Product Specifications

Brand: CRC Press
Format: hardcover
ASIN: 1420073540
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain: Amazon UK
Release Date: 11 August 2008
Listed Since: 10 October 2007

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CRC Press FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

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