Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

  • Linda Fossati Wood
  • MaryAnn Foote

Table of contents

  1. Front Matter
    Pages i-x
  2. Regulatory writing fundamentals

    1. Front Matter
      Pages 1-1
    2. Linda Fossati Wood
      Pages 3-23
  3. Getting started

    1. Front Matter
      Pages 25-25
    2. Linda Fossati Wood
      Pages 27-32
    3. Linda Fossati Wood, MaryAnn Foote
      Pages 45-50
  4. Source documents

    1. Front Matter
      Pages 51-51
    2. Linda Fossati Wood
      Pages 53-68
    3. Linda Fossati Wood
      Pages 69-102
  5. Integrated documents

    1. Front Matter
      Pages 103-103
    2. Linda Fossati Wood
      Pages 105-119
    3. Linda Fossati Wood
      Pages 121-124
    4. Jennifer A. Fissekis
      Pages 125-130
    5. Jennifer A. Fissekis
      Pages 131-137
  6. Regulatory submissions

    1. Front Matter
      Pages 139-139
    2. Takumi Ishida, Katsunori Kurusu
      Pages 155-174
  7. Back Matter
    Pages 187-237

About this book

Introduction

This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.

Keywords

Style clinical trial drugs safety

Editors and affiliations

  • Linda Fossati Wood
    • 1
  • MaryAnn Foote
    • 2
  1. 1.Medwrite Inc.WestfordUSA
  2. 2.MA Foote AssociatesWestlake VillageUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-7643-8362-6
  • Copyright Information Birkhäuser Basel 2009
  • Publisher Name Birkhäuser Basel
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-3-7643-8361-9
  • Online ISBN 978-3-7643-8362-6
  • About this book