FDA Regulatory Affairs Third Edition

Name: FDA Regulatory Affairs Third Edition
Price: 51.57 USD
Availability: InStock
ISBN: 9781841849195

ISBN-10: 1841849197

ISBN-13: 9781841849195

Edition: 3rd 2014 (Revised)

Authors: David Mantus, Douglas J. Pisano

List price: $150.00

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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 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.

Book details

List price: $150.00
Edition: 3rd
Copyright year: 2014
Publisher: Taylor & Francis Group
Publication date: 2/28/2014
Binding: Hardcover
Pages: 400
Size: 6.25" wide x 9.00" long x 1.00" tall
Weight: 1.650
Language: English

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