The climate inside the FDA has never been more challenging for companies seeking new product approvals. Problems with safety, efficacy and unexpected side effects of approved products have put the agency on high alert. The result is tougher reviews, more questions and — most importantly — more rejections. Failure to anticipate even the smallest details can cost your company tens of millions or even hundreds of millions of dollars, and damage your reputation.

Finally, there is one book that provides all the tools you need to prepare for an FDA advisory committee meeting, from detailed timelines and messaging tips to rules for crafting effective slides and handling the toughest questions. Introducing:

The FDA Advisory Committee Survival Manual
A Step-by-Step Guide to Preparing for a Successful Hearing

Authored by veteran drug and device industry execs with years of advisory committee experience behind them, the Survival Manual identifies the biggest hurdles you'll face in preparing for an advisory committee meeting, and the steps to overcome those hurdles. This one-of-a-kind book covers the following topics:

• The Briefing Book. Due 22 days ahead of presentation, the briefing book is essential to your success. Think no one reads it? Think again. It needs to succinctly and persuasively capture the benefits of your product because it will be the advisory committee's first look at it. The FDA Advisory Committee Survival Manual will show you how to prepare a briefing book that will make a powerful and positive first impression.

• The Timeline. Starting preparations too late is one of the most common mistakes companies make in preparing for an advisory committee. With the 16-week, tried-and-tested calendar developed by our authors, you'll keep your proposal on track and be fully prepared when you step before the committee.

• Roles and Responsibilities. The eight-team approach to preparing for a committee meeting assures companies that they will have the right people taking the right steps at the right time throughout the preparation process.

• Background Research. You know all about your product, but what do you know about the people who will be reviewing it? With 50 diverse advisory committees chartered by the FDA, a one-size-fits-all approach to preparation won't work. The Survival Manual shows you how to conduct appropriate background research on committee members so that your presenters will never hear a question for the first time in the meeting  room.

• Dress Rehearsal. A badly structured practice session for a committee meeting can be a waste of time and a distraction. With the communication tips in the Survival Manual, you'll know when to start practicing your presentation, and each session will advance you toward a more polished finished product.

• Presentation Perfection. The data are right, but is your case clear? Advisory committee presentations frequently falter not because the data aren't accurate or persuasive, but because they aren't presented in a way that clearly tells the story of your product. The Survival Manual provides simple rules for making your presentation uncluttered and effective.

For years 3D Communications has coached pharmaceutical, biotech and device companies to make successful presentations to FDA advisory committee meetings.  There’s no theoretical, canned advice in this new report — just real-life experiences and practical tips, described in plain English.

The report walks you through the entire advisory committee process, from the earliest stages of preparation through essential critiquing and refining of presentation materials … from understanding who sits on advisory committees and how they operate to rehearsing your presentation … and concluding with practical guidance for the days after the presentation.

You’ll also find invaluable insights and advice from a Who’s Who in the pharma and device world, including the FDA, Parexel, GlaxoSmithKline, Shire, Procter & Gamble and more.

The FDA Advisory Committee Survival Manual is a must-read for regulatory affairs professionals and consultants/service providers.

Don’t put your investment and products at risk — send for The FDA Advisory Committee Survival Manual today. Face your advisory committee meeting with confidence.

Buy Now!

About the Publisher:  3D Communications is a strategic communications firm made up  of former pharmaceutical and business executives, communications strategists, and award-winning writers and journalists. With more than 30 clients in the life sciences industries, 3D provides expert preparation and guidance for companies appearing before FDA advisory committees.

The FDA Advisory Committee Survival Manual is available from FDAnews now.

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