FDA's Drug Review Process and the Package Label

FDA's Drug Review Process and the Package Label

Strategies for Writing Successful FDA Submissions

1st Edition - December 1, 2017

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  • Author: Tom Brody
  • Paperback ISBN: 9780128146477
  • eBook ISBN: 9780128146484

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FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label.

Key Features

  • Reveals strategies for winning FDA approval and for drafting the package label
  • Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases
  • This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug


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

Product details

  • No. of pages: 670
  • Language: English
  • Copyright: © Academic Press 2017
  • Published: December 1, 2017
  • Imprint: Academic Press
  • Paperback ISBN: 9780128146477
  • eBook ISBN: 9780128146484

About the Author

Tom Brody

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 Clinical Trials, 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

Consultant for Second Genome, Inc. (Crohn's disease), Rigel Pharmaceuticals (platelet disorder), PrimeGen Biotech (stem cell therapy), Regeneron Pharmaceuticals (broadly neutralizing antibodies for HIV), and Biogen IDEC (multiple sclerosis)

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