Author:
Edition: 2
Binding: Hardcover
ISBN: 1420073540
Edition: 2
Binding: Hardcover
ISBN: 1420073540
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
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 FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, ISBN-13: 9781420073546, ISBN-10: 1420073540 Read medical textbooks online like FDA Regulatory Affairs here
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics: David Mantus, Douglas J. Pisano
format hardback language english publication year 11 08 2008 subject engineering technology subject 2 industrial chemistry manufacturing ean 9781420073546 title fda regulatory affairs sku st 1420073540 product category books comics magazines about hive store ltd by continuing with this checkout and ordering from hive you are accepting our current terms and conditions details of which can be found by clicking here author biography douglas j pisano is dean of the school of pharmacy and professor o
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 Editionfocuses 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: provid
"This book covers the regulatory process for getting pharmaceuticals, biologics, and medical devices approved. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing. Topics include: the drug approval process, Current Good Manufacturing Practices, Good Clinical Practices, Quality System Compliance and the corresponding documentation requirements, and FDA inspection processes and enforcement options. Although many references exist on this subject, this one is written in a general pro
FDA Regulatory Affairs Online
FDA Regulatory Affairs: provides a blueprint to the FDA and drug, biologic, and medical device development offers current, real
