Regulatory Writing: An Overview (subscription)

Lisa DeTora, PhD, editor

Contributing Authors

About the Book

Available formats: print, e-book, and 3-year digital subscription

Regulatory Writing: An Overview, Third Edition, offers a practical, experience-based guide to the purpose, preparation, and review of regulatory documentation across the product lifecycle.

Covering pharmaceuticals, biologics, medical devices, combination products, and more, this updated edition reflects recent regulatory changes, introduces new topics such as the European Union Clinical Trials Information System (EU CTIS), and addresses the growing role of AI in regulatory documentation—making it an essential resource for professionals involved in developing, reviewing, or managing regulatory documents.

This edition is organized into four sections covering general considerations, clinical documentation, integrated documentation, and special topic areas. Regulatory documentation is developed under a range of working conditions, and this book reflects those varied contexts while emphasizing coordination across contributors. Readers are encouraged to verify current requirements with relevant health authorities prior to preparing or submitting regulatory documents.

Lead Editor

Lisa DeTora, PhD, is a professor and director of STEM Writing at Hofstra University, where she serves as the Chairperson of the Department of Writing Studies and Rhetoric and guest lecturer in Medical Humanities and Narrative Medicine at the Zucker School of Medicine at Hofstra/Northwell.

Lisa edited the first two editions of Regulatory Writing: An Overview. She is also the first author of Good Publication Practice guidelines for company-sponsored biomedical research: 2022 update, which appeared in Annals of Internal Medicine. She has published on topics including publication ethics, the rhetoric of health and medicine, the rhetoric of science, technical communication, and health humanities. She also researches and teaches courses on comic books and science fiction.

Who will benefit from this book?

• Regulatory affairs professionals
• Medical writers
• Subject-matter experts involved in regulatory documentation
• Professionals seeking an introduction to, or refresher on, regulatory writing practices
• Teams involved in preparing, reviewing, or managing regulatory submissions

Purchasing Options

This book can be purchased in the following formats:

• Subscription.* A three-year subscription including the digital e-book version as well as automatic updates whenever a new edition and/or chapters are released during the subscription period. Learn more about the subscription.
• Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
• Printed book.

This book can also be purchased as part of the following bundles:

• All Access Library (12-month digital subscription)

*All subscriptions listed above (excluding the All Access Library) are for three years. They grant you access to the products in the bundle. During this period, you can read the content online or download books as PDFs for offline use. You’ll also receive automatic updates to any new editions of the books and/or chapters included in your subscription. Learn more about subscriptions.

Published by RAPS © 2026. Paperback. 247 pages. ISBN (print): 978-1-947493-99-5. ISBN (digital): 978-1-947493-98-8. Library of Congress Control Number: 2025948279.