FDA Regulatory Affairs

392 Pages·2013·26.55 MB·English

by  Pisano

Mantus T h i r d E d iT i o n
Medicine Pisano
FDA

Regulator y Affairs
T h i r d E d iT i o n
FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and
medical device development in the United States. Written in plain English, the
concise and jargon-free text demystifies the inner workings of the US Food and
Drug Administration (FDA) and facilitates an understanding of how the agency
operates with respect to compliance and product approval, including clinical
trial exemptions, fast track status, advisory committee procedures, and more.
The Third Edition of this highly successful publication:
• Examines the harmonization of the US Federal Food, Drug, and
Cosmetic Act with international regulations on human drug, biologics
and device development, research, manufacturing, and marketing
• Includes contributions from experts at organizations such as the FDA,
National Institutes of Health (NIH), and PAREXEL
• Focuses on the new drug application (NDA) process, cGMPs, GCPs,
quality system compliance, and corresponding documentation
requirements
• Provides updates to the FDA Safety and Innovation Act (FDASIA),
FDA
incorporating pediatric guidelines and follow-on biologics regulations
from the 2012 Prescription Drug User Fee Act (PDUFA) V
• Explains current FDA inspection processes, enforcement options, and

how to handle FDA meetings and required submissions
Co-edited by an industry leader (Mantus) and a respected academic (Pisano),
FDA Regulatory Affairs, Third Edition delivers a compilation of the selected
Regulator y Af fairs
US laws and regulations as well as a straightforward commentary on the FDA
product approval process that’s broadly useful to both business and academia.
Third
EdiTion
H100295 Edited by
ISBN-13: 978-1-84184-919-5
90000
David Mantus
Douglas J. Pisano
9 781841 849195
H100295_Cover_mech.indd All Pages 12/12/13 11:46 AM
T h i r d E d iT i o n
FDA

Regulator y Affairs

T h i r d E d iT i o n
FDA

Regulator y Af fairs
Edited by
David Mantus
Douglas J. Pisano
Boca Raton London New York
CRC Press is an imprint of the
Taylor & Francis Group, an informa business
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Contents
Preface.................................................................................................................vii
Editors ..................................................................................................................ix
Contributors .........................................................................................................xi
Chapter 1 Overview of FDA and Drug Development ......................................1
Josephine C. Babiarz and Douglas Pisano
Chapter 2 What Is an IND? ...........................................................................41
Michael R. Hamrell
Chapter 3 The New Drug Application ...........................................................77
Charles Monahan and Josephine C. Babiarz
Chapter 4 Meetings with the FDA ...............................................................105
Alberto Grignolo and Sally Choe
Chapter 5 FDA Medical Device Regulation ................................................125
Barry Sall
Chapter 6 A Primer of Drug/Device Law: What Is the Law
and How Do I Find It? .................................................................169
Josephine C. Babiarz
Chapter 7 The Development of Orphan Drugs ............................................189
Scott N. Freeman
Chapter 8 CMC Sections of Regulatory Filings and CMC Regulatory
Compliance during Investigational and Postapproval Stages .....199
Prabu Nambiar, Steven R. Koepke, and Kevin Swiss
v
© 2010 Taylor & Francis Group, LLC
vi Contents
Chapter 9 Overview of the GxPs for the Regulatory Professional ..............235
Bob Buckley, Robert Blanks, Kimberly J. White,
and Tonya White-Salters
Chapter 10 FDA Regulation of the Advertising and Promotion
of Prescription Drugs, Biologics, and Medical Devices .............285
Karen L. Drake, Esq.
Chapter 11 The Practice of Regulatory Affairs .............................................309
David S. Mantus
Chapter 12 FDA Advisory Committees.........................................................327
Christina A. McCarthy and David S. Mantus
Chapter 13 Biologics ......................................................................................347
Florence Kaltovich
Chapter 14 Regulation of Combination Products in the United States..........361
John Barlow Weiner, Esq.
© 2010 Taylor & Francis Group, LLC
Preface
This book is a roadmap to the U.S. Food and Drug Administration (FDA) and
drug, biologic, and medical device development. The book is written in plain
English, with an emphasis on easy access to understanding how this Agency oper-
ates with respect to the practical aspects of U.S. product approval. It is meant to
be a concise reference that offers current, real-time information. It has been writ-
ten as a handy reference for use by students, staff, and professionals at corpora-
tions, o rganizations, and schools and colleges across the United States in need of a
simple, concise text from which to learn and teach. The topics in FDA Regulatory
Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second
Edition, are covered in a straightforward format. It is a compilation and commen-
tary of selected laws and regulations pertaining to the development and approval of
drugs, biologics, and medical devices in the United States. It is not intended to take
the place of an actual reading of the laws of the United States of America or the
regulations of the United States, its agencies or anybody that regulates the devel-
opment or approval of drugs, biologics, and medical devices in the United States.
David S. Mantus
C after D Inc.
Douglas J. Pisano
Massachusetts College of Pharmacy and Health Sciences
vii
© 2010 Taylor & Francis Group, LLC

Editors
Dr. David S. Mantus, PhD, worked in the biotechnology and p harmaceutical
industry for more than 20 years. He served as vice president, Regulatory Affairs
at Cubist Pharmaceuticals until 2011. Prior to joining Cubist, Dr. Mantus served
as vice president, Regulatory Affairs at Sention, Inc., and held various regulatory
roles at Shire Biologics, PAREXEL, the Massachusetts Public Health Laboratory,
and Procter & Gamble Pharmaceuticals. Dr. Mantus received his BS in chemis-
try from the College of William and Mary, and his MS and PhD in chemistry
from Cornell University. He was a postdoctoral research fellow in biomedical
engineering at the University of Washington. He currently resides in Bolton, MA.
Douglas J. Pisano is a professor of social and administrative sciences at the
Massachusetts College of Pharmacy and Health Sciences (MCPHS) University.
He began his career at the University in the Fall of 1984 and has maintained a
full-time faculty appointment and is a member of the graduate faculty. In 1998,
he became the founder and director of the master of science degree in r egulatory
affairs and health policy and served in that role until 2010. In the year 2000,
he became the dean of the newly established School of Pharmacy—Worcester.
Its cutting-edge accelerated Doctor of Pharmacy program was instrumental in
establishing a companion program using distance education technology at the
college’s Manchester campus. In June 2005, Dr. Pisano became the associate
provost for Pharmacy Education and dean of the School of Pharmacy at Boston
where he was charged with blending, coordinating, and overseeing many of the
aspects of the college’s three distinct and accredited Doctor of Pharmacy pro-
grams, which extend over three campuses into a single face of pharmacy for the
college overall. His pharmacy deanship also included the oversight of the 12 pro-
grams in the School of Graduate Studies and the Office of Pharmacy Experiential
Education. He has also served as interim dean for the School of Medical Imaging
and Therapeutics and Physician Assistant Studies. Dr. Pisano currently serves as
vice president of academic affairs and provost for the university.
ix
© 2010 Taylor & Francis Group, LLC