Despite this enormous investment of time and money, the success rate for getting new drugs approved by the FDA is declining.
The FDA Advisory Committee Manual is a 159-page book written by 3D Communications to help prepare and guide companies through the FDA advisory committee approval process. Click here to order your copy today.
Increasing product withdrawals and recalls, heightened concerns about patient safety, and a maelstrom of criticism around the FDA and the pharmaceutical industry have created a climate of public fear and mistrust. As a result, the FDA is requiring companies to provide more data and often to present their data at highprofile, emotionally charged FDA advisory committee meetings — hearings that often determine whether the product will ultimately gain approval.
Preparing for an FDA advisory committee meeting is more challenging than ever. While there is no single magic key to success and clearly no substitute for good data, there are critical steps that companies should take to increase the odds that the advisory committee will agree with the sponsor that their drug or device should be approved:
- truly understanding the FDA and advisory committee’s real concerns throughout the product development process;
- honestly addressing the product’s strengths and weaknesses; and
- clearly communicating the story around the product in a way that helps convince the committee that the sponsor’s program supports a favorable benefit-to-risk ratio.
More than anything else, advisory committee preparation requires that companies organize a dedicated, focused team that plans to win — but works as if it’s one step away from losing.
Table of Contents
Introduction
Chapter 1. Maximizing FDA Interactions Before and During Advisory
Committee Preparation
Planning
Chapter 2. Selecting, Organizing, and Managing the Team
Chapter 3. Researching and Analyzing the Advisory Committee Members
Chapter 4. Analyzing the Environment and Leveraging Advocacy Support
Preparation
Chapter 5. Creating, Prioritizing, and Harmonizing Content
Chapter 6. Writing the Briefing Book
Chapter 7. Writing the Core Presentation
Chapter 8. Creating Slides and Visual Aids
Chapter 9. Creating, Managing, and Using Backup Slides
Practice
Chapter 10. Practicing the Core Presentation
Chapter 11. Preparing for the Q&A
Chapter 12. Organizing Mock Advisory Committee Meetings
Wrapup
Chapter 13. Working With the Media
Chapter 14. Handling Game-Day Communications and Logistics
Chapter 15. A Final Word
Appendices
Appendix I. Glossary
Appendix II. How the FDA Advisory Committee Hearing Process Works
Appendix III. Special Considerations: Rx-to-OTC Switches, Devices,
and Combination Products
Appendix IV. FDAAA Legislation and Post-Marketing Safety Commitments
The FDA Advisory Committee Manual is a 159-page book written by 3D Communications to help prepare and guide companies through the FDA Advisory Committee approval process. Click here to order your copy today.
