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The Biotech CEO's Guide to Your First FDA Meeting
Paperback
Series: Cambase Executive Field Guides, Book 1
Publisher: Independently Published
Published: Sep 3 2026
Pages: 28
Weight: 0.15
Height: 0.07 Width: 6.00 Depth: 9.00
Language: English
Your first FDA meeting could shape the future of your entire development program.
But many biotech teams prepare for it as a regulatory event rather than a strategic decision point.
They focus on the meeting request, briefing package, questions, and presentation-without first agreeing on what the company needs to learn, which decisions FDA's feedback must inform, or how the program will respond if the agency takes a different view.
The Biotech CEO's Guide to Your First FDA Meeting offers a practical, executive-level framework for preparing more strategically.
Written by Nilou Sarah Arden, PhD-a former FDA regulator and global biopharma regulatory leader-the guide helps biotech founders, CEOs, executives, and development teams look beyond the mechanics of the meeting and ask a more important question:
What must this FDA interaction enable us to decide?
Inside, you will learn how to:
- Define the decisions for which your company needs FDA input
- Identify the most consequential uncertainties in your development plan
- Prioritize questions that could materially change the program
- Distinguish evidence, assumptions, beliefs, and unresolved uncertainty
- Integrate CMC, nonclinical, clinical, and regulatory strategies
- Recognize which questions should not be asked-or should not be asked yet
- Build a briefing package that supports clear, decision-useful feedback
- Prepare for disagreement, conditional advice, and unexpected responses
- Decide which commitments should be made now and which can wait
- Align the leadership team before entering the meeting
The guide also includes:
- A one-page FDA meeting strategy
- A five-minute strategic-readiness diagnostic
- A CEO checklist for final preparation
- A post-meeting framework for turning regulatory feedback into decisions, actions, and organizational learning
This is not a technical manual for writing an FDA briefing package. It is a field guide for leading the decisions around one.
Whether your company is preparing for a pre-IND meeting, an initial regulatory interaction, or another consequential FDA milestone, this guide will help you connect regulatory strategy to the wider development pathway-including evidence, manufacturing, clinical planning, capital, sequencing, risk, and future options.
Because a successful FDA meeting is not simply one that goes smoothly.
It is one that helps the company make better decisions.
Part of the Cambase Executive Field Guides series: practical intelligence for the decisions shaping the path from science to patients.
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