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The Briefing Book

The Briefing Book is, in my opinion, one of the most critical documents in Regulatory Affairs. This is your opportunity to tell your story to the FDA in a setting which, while controlled by the FDA, you in, Regulatory Affairs, manage. The purpose of this document is to give background to the FDA in the questions you have already sent them as part of a meeting request. This is why I call it "your story".

The key thing to remember with any briefing book is that you need to be able to give your audience enough information so that they will come to the conclusion you wish them to arrive at. This usually means ensuring that your data is presented, in at least some limited form, and also that it conforms to the story you are trying to tell.

So what is this story? This is the story of your drug or biologic from start to finish. It is the story of your Pre-Clinical program, which led you through Animal testing, and determining your initial animal PK and toxicology. It is the story of your Phase 1 Proof of Concept Trial. It is your Safety, Efficacy, and Dose Ranging Phase 2 Studies. It may even be your Phase 3 Pivotal Study if you are pursuing a traditional approval path, and not an accelerated one.

Your briefing book is your biggest key to initially influencing the Health Authorities. With your meeting request, you will have submitted questions. These are usually presented with either a brief introduction or no detail at all, so the Agencies just know what you asked, but not why you asked it. A good example of this is a question such as: "Does the Agency agree that the safety database, comprised of more than XXX patients exposed to study drug across all tumor types, will be sufficient to support accelerated approval of the BLA?"

The Agency is going to want to know how many different tumor types were looked at. What the specific safety outcomes were in the one you are specifically trying to get approved for as part of your indication. How many Adverse Events vs. Serious Adverse Events occurred. How it compared to standard of care, or, when possible, placebo. All of these questions, you should plan on answering in your briefing book.

Giving the Agencies as much information as possible to both understand your questions, and understand why you have chosen the position you have, will lead not only to replies which are in line with your wishes, but will also help improve the Agencies understanding of similar programs. For all these reason, this is why I say that the Briefing Document is one of your most critical.

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