FDA Regulatory Affairs, Third Edition

ISBN-10: 1841849197
ISBN-13: 9781841849195
Edition: 3rd 2014 (Revised)
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Description: This third edition of FDA Regulatory Affairsexamines 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. Focusing on  More...

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Book details

List price: $99.00
Edition: 3rd
Copyright year: 2014
Publisher: CRC Press LLC
Publication date: 1/23/2014
Binding: Hardcover
Pages: 400
Size: 6.25" wide x 9.00" long x 1.00" tall
Weight: 1.672
Language: English

This third edition of FDA Regulatory Affairsexamines 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. Focusing on new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements this is a key title for anyone involved in pharmaceutical regulation. Jargon-free and drawing information from a wide range of resources, this book demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

Douglas Pisano, R.Ph., is Assistant Professor of Pharmacy Administration at Massachusetts College of Pharmacy and Allied Health Sciences, Boston, Massachusetts.

Overview of FDA and Drug Development
What is an IND? The New Drug Application
Meeting with the FDA
FDA Medicine Device Regulation
The Development of Orphan Drugs
CMC Sections of Regulatory Filings and CMC Regulatory Compliance During Investigational and Post-approval Stages
Overview of GxPs for the Regulatory Professional
FDA Regulation of the Advertising and Promotion of Prescription Drugs, Biologics and Medical Devices
Electronic Submissions-a Guide for Electronic Regulatory Submissions to FDA
The Practice of Regulatory Affairs
A primer of Drug/Device Law
FDA Advisory Committees
Biologics

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