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-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

Author Notes

DOUGLAS J. PISANO is Dean of the School of Pharmacy and Professor of Pharmacy Administration, Massachusetts College of Pharmacy and Health Sciences, Boston, Massachusetts, USA. Dr. Pisano received his Ph.D. in Law, Policy, and Society at Northeastern University, Boston, Massachusetts, USA. He is an active member of several professional organizations, including the American Association of Colleges of Pharmacy and the American Pharmaceutical Association. A national speaker and invited lecturer, Dr. Pisano was the recipient of the Special Service Award for the Enhancement of Regulatory Education from the Regulatory Affairs Professionals Society in 2000. He has developed several courses and programs at the Massachusetts College of Pharmacy and Health Sciences in such areas as health policy, pharmacy and drug law, and regulatory affairs. Dr. Pisano, along with coeditor Dr. David S. Mantus, is also the editor of the first edition of Informa Healthcare's FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics.

DAVID S. MANTUS is Vice President of Regulatory Affairs and Program Management, Cubist Pharmaceuticals, Inc., Lexington; Adjunct Professor of Drug Regulatory Affairs, Massachusetts College of Pharmacy and Health Sciences, Boston; and President, C After D Inc., Boston, Massachusetts, USA. Dr. Mantus received his Ph.D. in Chemistry from Cornell University, Ithaca, New York, USA. He is an active member of the Regulatory Affairs Professional Society and the American Chemical Society and is a frequent presenter and lecturer at national conferences on biologics and biotechnology, regulatory affairs, and vaccine development. Dr. Mantus has also served as chairperson for several conferences, including "Outsourcing Regulatory Affairs" and "Vaccine Development for the 21st Century."

Josephine C. Babiarz and Douglas J. PisanoMichael R. HamrellCharles Monahan and Josephine C. BabiarzAlberto GrignoloBarry SallTan T. NguyenPrabu Nambiar and Steven R. KoepkeBob Buckley and Robert BlanksKaren L. DrakeShylendra Kumar and Yolanda Hall and Vahe GhahramanDavid S. MantusJosephine C. BabiarzChristina A. McCarthy and David S. MantusTimothy A. Keutzer

Preface	p. iii
Contributors	p. vii
1 Overview of FDA and Drug Development	p. 1
2 What Is an IND?	p. 33
3 The New Drug Application	p. 69
4 Meeting with the FDA	p. 109
5 FDA Medical Device Regulation	p. 125
6 The Development of Orphan Drugs	p. 167
7 CMC Sections of Regulatory Filings and CMC Regulatory Compliance During Investigational and Postapproval Stages	p. 187
8 Overview of the GxPs for the Regulatory Professional	p. 213
9 FDA Regulation of the Advertising and Promotion of Prescription Drugs, Biologics, and Medical Devices	p. 267
10 Electronic Submissions-A Guide for Electronic Regulatory Submissions to FDA	p. 289
11 The Practice of Regulatory Affairs	p. 351
12 A Primer of Drug/Device Law: What's the Law and How Do I find It?	p. 369
13 FDA Advisory Committees	p. 397
14 Biologics	p. 417
Index	p. 435

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Summary

Summary

Author Notes

Table of Contents