FDA's Drug Review Process and the Package Label - 1st Edition - ISBN: 9780128146477

FDA's Drug Review Process and the Package Label

1st Edition

Strategies for Writing Successful FDA Submissions

Authors: Tom Brody
Paperback ISBN: 9780128146477
Imprint: Academic Press
Published Date: 1st March 2018
Page Count: 410
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FDA's Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions provides a guide to pharmaceutical companies on how to write FDA-submissions. This book covers all essential elements in FDA-approval, including Clinical Study Reports, Investigator's Brochures and the Common Technical Document (eCTD). Specifically, the book provides guidance to medical writers in the pharmaceutical industry for drafting FDA-submissions that will persuade reviewers to grant approval to drugs. The book contains excerpts copied from various package labels, demonstrating how a sponsor's arguments, together with feedback, complaints and suggestions from FDA reviewers guides the writing of package labels.

This book is essential for pharmaceutical companies, those studying or researching in drug discovery, and all involved in the biotechnology industry, from research to regulation.

Key Features

  • Demonstrates specific techniques and strategies for FDA approval
  • Includes numerous real-life examples to guide writing
  • Drawn from the most reliable source of information available by a veteran in the industry


Pharmaceutical and biotechnology industry scientists and companies, pharmacology and pharmaceutical science students and researchers who are interested in learning or need to participate in the FDA drug review process. Law firms and law schools with an interest in the regulatory role of the FDA

Table of Contents

1.  Introduction
2.  FDA's decision-making process when assessing ambiguous data
3.  Food effect studies
4.  Dose modification and dose titration
5.  Contraindications
6.  Animal studies
7.  Drug-drug interactions -- Part One (small molecule drugs)
8.  Drug-drug interactions -- Part Two (therapeutic proteins)
9.  Immunosuppression, drug-induced hypersensitivity reactions, and drug-induced autoimmune reactions
10.  Drug class analysis
11.  Relatedness
12.  Adjudication of clinical data
13.  Coding
14.  Pooling


No. of pages:
© Academic Press 2018
Academic Press
Paperback ISBN:

About the Author

Tom Brody

Dr. Tom Brody received his PhD from the University of California at Berkeley in 1980, and conducted postdoctoral research at University of Wisconsin-Madison and also at U.C. Berkeley. His 20 research publications concern the metabolism and pharmacology of folates, cloning an anti-cancer gene (XPE gene), and the structure of an antibody (natalizumab) used for treating multiple sclerosis. The author has 15 years of pharmaceutical industry experience, acquired at Schering-Plough, Cerus Corporation, and Elan Pharmaceuticals, and has contributed to FDA submissions for the indications of multiple sclerosis, melanoma, head and neck cancer, liver cancer, pancreatic cancer, and hepatitis C. At an earlier time, he wrote two editions of Nutritional Biochemistry, published by Elsevier, Inc. The author has 16 years of training and experience in the Code of Federal regulations, as it applies to pharmaceuticals and clinical trial design.

Affiliations and Expertise

Contract Researcher, Baker Hostetler, San Francisco, CA, USA