Description: FDA Regulatory Affairs Please note: this item is printed on demand and will take extra time before it can be dispatched to you (up to 20 working days). A Guide for Prescription Drugs, Medical Devices, and Biologics Author(s): Douglas J. Pisano, David S. Mantus Format: Hardback Publisher: Taylor & Francis Inc, United States Imprint: CRC Press Inc ISBN-13: 9781420073546, 978-1420073546 Synopsis 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
Price: 150.27 GBP
Location: Aldershot
End Time: 2024-11-12T09:33:19.000Z
Shipping Cost: 49.96 GBP
Product Images
Item Specifics
Return postage will be paid by: Buyer
Returns Accepted: Returns Accepted
After receiving the item, your buyer should cancel the purchase within: 60 days
Return policy details:
Book Title: FDA Regulatory Affairs
Number of Pages: 464 Pages
Language: English
Publication Name: Fda Regulatory Affairs: a Guide for Prescription Drugs, Medical Devices, and Biologics
Publisher: Taylor & Francis INC International Concepts
Publication Year: 2008
Item Height: 229 mm
Item Weight: 862 g
Type: Textbook
Author: David S. Mantus, Douglas J. Pisano
Subject Area: Chemical Engineering
Item Width: 152 mm
Format: Hardcover
