FDA Regulatory Affairs Third Edition

Preface

Editors

Contributors

Overview of FDA and Drug Development
Josephine C. Babiarz and Douglas Pisano

What Is an IND?
Michael R. Hamrell

The New Drug Application
Charles Monahan and Josephine C. Babiarz

Meetings with the FDA
Alberto Grignolo and Sally Choe

FDA Medical Device Regulation
Barry Sall

A Primer of Drug/Device Law: What Is the Law and How Do I Find It?
Josephine C. Babiarz

The Development of Orphan Drugs
Scott N. Freeman

CMC Sections of Regulatory Filings and CMC Regulatory Compliance during Investigational and Postapproval Stages
Prabu Nambiar, Steven R. Koepke, and Kevin Swiss

Overview of the GxPs for the Regulatory Professional
Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters

FDA Regulation of the Advertising and Promotion of Prescription Drugs, Biologics, and Medical Devices
Karen L. Drake, Esq.

The Practice of Regulatory Affairs
David S. Mantus

FDA Advisory Committees
Christina A. McCarthy and David S. Mantus

Biologics
Florence Kaltovich

Regulation of Combination Products in the United States
John Barlow Weiner, Esq.

Index

Biography

David Mantus worked in the biotechnology and pharmaceutical industry for more than 20 years. He not only served as vice president of regulatory affairs at Cubist Pharmaceuticals but also held various regulatory roles at Sention Inc., Shire Biologics, PAREXEL, the Massachusetts Public Health Laboratory, the Massachusetts College of Pharmacy and Health Sciences, and Procter and Gamble Pharmaceuticals. He received his BS in chemistry from the College of William and Mary, his MS and Ph.D in chemistry from Cornell University, and was a post-doctoral research fellow in biomedical engineering at the University of Washington. He is currently associate professor of pharmaceutical sciences and director, regulatory affairs at MCPHS University in Boston.

Douglas J. Pisano received his Ph.D in law, policy, and society from Northeastern University. He has participated on the editorial advisory boards of multiple journals and received the Special Service Award for the Enhancement of Regulatory Education from the Regulatory Affairs Professionals Society. A registered pharmacist and active member of several professional organizations, including the American Association of Colleges of Pharmacy and the Regulatory Affairs Professionals Society, he formerly served as dean of the School of Pharmacy–Boston and is currently professor of pharmacy administration, vice-president of academic affairs, and provost at MCPHS University in Boston.

"This book covers the myriad of topics related to the development and marketing of all types of drugs and devices regulated by the U.S. Food and Drug Administration. The book discusses not only the relevant regulations, but also the administrative processes that sponsors must deal with in getting their products approved for marketing. ... This book covers many of the important issues in enough depth to answer basic questions related to the components of an IND (investigational new drug) and an NDA (new drug application), as well as IDE (investigational device exemption) and 510k applications. ... This book fulfills a unique need for those seeking a book for a course in drug and device development or for those in the industry who seek information outside of their area of expertise."
—Michael R. Jacobs, BS, PharmD, Temple University School of Pharmacy, in Doody's Book Reviews