2nd Edition

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

ISBN 9781420073546
Published August 11, 2008 by CRC Press
464 Pages 52 B/W Illustrations

USD $200.00

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Book Description

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

Table of Contents

Ch.1 - Overview Of Drug Development And The FDA: Josephine Babiarz

Ch.2 - IND: Michael R. Hamrell

Ch.3 - Formatting, Assembling, And Submitting A CTD (NDA): Charles Monahan III

Ch.4 - Meeting with the FDA: Alberto Grignolo

Ch.5 – Biologics: J. Kenimer

Ch.6 - FDA Medical Device Regulation: Barry Sall

Ch.7 - The Development of Orphan Drugs: Tan Nguyen

Ch.8 - Chemistry, Manufacturing and Control Issues: Drugs and Biologics: Prabu Nambiar

Ch. 9 - Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices: Robert Buckley

Ch.10 - The Regulation of Promotional Materials And Advertising For Drugs: Karen Drake

Ch.11 - CTD SUBMISSIONS: A Guide For Electronic Regulatory Submissions to FDA: Shylendra Kumar, Yolanda Hall, Vahé Ghahraman

Ch.12 - The Practice Of Regulatory Affairs: Dave Mantus

Ch. 13 - A Primer Of Drug/Device Law Or What's The Law And How Do I Find It? Josephine Babiarz

Ch.14 - Advisory Committee System at FDA: Christina McCarthy

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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."