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

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and BiologicsPublisher: Informa HealthCare English ISBN: 1420073540 464 pages 2008 PDF 6 MbDescription: 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.

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Pharmaceutical Guidelines

Common Technical Document:
ASEAN
ICH

GMP -Drug Product:
INDIA
PIC
USFDA
WHO 

GMP-Drug substances:
ICH
PIC
USFDA
WHO 

ICH Guidelines:
Efficacy
Multidisciplinary
Quality
Safety 

Regulatory Audits:
PIC
WHO

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Medical Product Regulatory Affairs

John J. Tobin, Gary Walsh, "Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices"
Wiley-VCH 2008 | ISBN-10: 3527318771 | 297 Pages | PDF | 7,3 MB 

This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing." –Microbiology Today, May 2009

Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices.

Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.

The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

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