The FDA Advisory Committee Survival Manual, 2nd Edition
Table of Contents
Introduction
Chapter 1: Prepare Early
Chapter 2: Convene the Team
Chapter 3: Target the Audience
Chapter 4: Engage Stakeholders
Chapter 5: Dissect the Data
Chapter 6: Build the Right Foundation
Chapter 7: Make a Good First Impression
Chapter 8: Tell the Story
Chapter 9: Visualize the Data
Chapter 10: Be Ready with Backup
Chapter 11: Check It. Check It Again.
Chapter 12: Stand and Deliver
Chapter 13: Respond and Resolve
Chapter 14: Get a Reality Check
Chapter 15: Speak to the Street
Chapter 16: Amplify the Message
Chapter 17: Game On!
Chapter 18: A Final Word
Appendix I: Listing of FDA’s Advisory Committees
Appendix II: Rx-to-OTC Switches
Appendix III: New Drug Application (NDA) Review Process
Appendix IV: Legislative and Regulatory Considerations
Appendix V: Glossary
References
Graphics and Photography
Book Reviews
3D Communications, Publisher
About the Book
Available formats: print and e-book
RAPS has teamed up with 3D Communications to offer The FDA Advisory Committee Survival Manual, 2nd Edition, an expanded step-by-step guide designed to help pharma, biotech, and medical device companies prepare for, and succeed at, US Food and Drug Administration (FDA) advisory committee meetings (ADCOMs).
The second edition outlines the pragmatic approach and processes that 3D Communications has developed and refined from nearly 500 ADCOMs over more than 20 years.
The book is organized into practical sections that walk readers through every phase of the ADCOM preparation process – addressing the biggest challenges sponsors face in achieving a successful ADCOM. These include: how to analyze the issues that matter to advisory committee members; how to assemble the right sponsor team; how to transform volumes of data into compelling messages and simple slides; how to answer challenging questions from committee members; and how to leverage technology throughout the preparation process and on the day of the ADCOM.
The second edition includes updated content on virtual and hybrid meetings, new templates and tools like the Key Message Grid and Objection Handler, and new chapters on engaging important stakeholders and conducting thorough quality control of data and slides.
Each chapter includes a "how-to" section with actionable tips and key takeaways, making it an invaluable resource for navigating the process with confidence and success.
Who will benefit from this book?
The FDA Advisory Committee Survival Manual, 2nd Edition is the ultimate guide for anyone facing an FDA advisory committee meeting.
Special Thanks to 3D Communications
3D Communications is donating all royalties from sales of this book to The RAPS Convergence Student Ambassador Program. This program empowers the next generation of regulatory professionals to attend RAPS Convergence, enhancing their regulatory education while providing important networking opportunities. By purchasing this book, you’re not only gaining valuable resources, but you’re also contributing to a meaningful cause.
Purchasing Options
This book can be purchased in the following formats:
- 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)
Published by RAPS © 2024. Paperback. 182 pages. ISBN: 978-0-9817635-0-7.
