FDA Meeting Request & Briefing Book Strategy and Preparation

Snow Consulting provides FDA Briefing Book Strategy, Preparation & Implementation with your team. We make sure your briefing book meets FDA’s stringent filing requirements and necessary components.

We Strategize and Prepare an Effective Briefing Book for Regulatory Success

In the realm of Regulatory Affairs, the Briefing Book is one of the most critical documents you will create. This document serves as your opportunity to present your narrative to the FDA in a setting where, although the FDA maintains control, you in Regulatory Affairs steer the discussion. The primary goal of the Briefing Book is to provide the FDA with the necessary background information on the questions you have already submitted as part of your meeting request. This is why we refer to it as “your story.”

Strategize, Then Present Your Narrative

When preparing your Briefing Book, it’s essential to give your audience sufficient information to arrive at the conclusion you desire. This often involves presenting your data in a clear and coherent manner that aligns with the narrative you are trying to convey.

What is Your Story?

Your story encompasses the entire journey of your drug or biologic, from inception to present day. It includes:

• Pre-Clinical Program: This section outlines your animal testing, initial pharmacokinetics (PK), and toxicology studies.
• Phase 1 Proof of Concept Trials: Here, you detail the early human trials that establish the initial safety and efficacy profile of your product.
• Phase 2 Studies: These studies focus on safety, efficacy, and dose-ranging, providing critical data to guide further development.
• Phase 3 Pivotal Studies: If pursuing a traditional approval path, this section would cover your large-scale trials designed to confirm efficacy and monitor adverse reactions.

The Role of the Briefing Book

The Briefing Book is your primary tool for influencing the Health Authorities at the outset. Your meeting request includes questions, typically presented with minimal context. The Agencies know what you asked but not the reasoning behind it. For example, consider the question:

“Does the Agency agree that the safety database, comprised of more than XXX patients exposed to the study drug across all tumor types, will be sufficient to support accelerated approval of the BLA?”

In response to this, the FDA will need detailed information such as:

• The number of different tumor types examined.
• Specific safety outcomes for the tumor type relevant to your indication.
• The number and nature of Adverse Events vs. Serious Adverse Events.
• Comparisons to the standard of care or placebo, where applicable.

Comprehensive Information is Key

To achieve favorable responses from the FDA, your Briefing Book should provide comprehensive information that explains both your questions and the rationale behind your positions. This not only helps secure responses aligned with your goals but also enhances the FDA’s understanding of similar development programs.

Conclusion

For all these reasons, the Briefing Book stands out as one of the most critical documents in your regulatory toolkit. By effectively telling your story and thoroughly addressing potential questions, you position your drug or biologic for a smoother regulatory review process.

So let Snow Consulting “guide you” or put together your briefing book or the part that you need, give us a call, 714-553-3736.

We look forward to discussing your needs with you!