FDA Regulatory Affairs pdf

Author:
Edition: 2
Publisher: CRC Press
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. Medical books FDA Regulatory Affairs. Medical books FDA Regulatory Affairs A Guide for Prescription Drugs, Medical Devices. Focusing on the new drug approval process, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition, examines cGMPs, GCPs, quality system compliance, and the corresponding documentation requirements, and the pertinent aspects of the Federal Food, Drug, and Cosmetic Act as they apply to human, drug, and device development, research, manufacturing, and marketing.

Download link for FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

Focusing on the new drug approval process, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition, examines cGMPs, GCPs, quality system compliance, and the corresponding documentation requirements, and the pertinent aspects of the Federal Food, Drug, and Cosmetic Act as they apply to human, drug, and device development, research, manufacturing, and marketing.

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, ISBN-13: 9781420073546, ISBN-10: 1420073540

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

Medical Book FDA Regulatory Affairs

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