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 provides a guide to pharmaceutical companies for writing 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 FDA reviewers to grant approval to the drug. Containing excerpts copied from various package labels to demonstrate how the Sponsor's arguments, together with feedback, complaints, and suggestions from FDA reviewers, this book guides the writing of the package label, the primary component of FDA approval (rather than the drug itself). 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 of 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. Food Effect
    3. Dose Modification and Titration
    4. Immunosuppressants and Drug Allergies
    5. Drug Class Analysis
    6. Drug-Drug Interactions
    7. Drug-Drug Interactions Involving Immune Response
    8. Animals for Assessing Drug Efficacy and Toxicity
    9. Contraindications
    10. Relatedness
    11. Adjudication
    12. Coding
    13. 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