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:
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.
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.
Your risk is zero when you purchase under our money-back guarantee. Not satisfied with the book? Return the hard copy within 30 days (in good condition) for a 100 percent refund of your purchase price (less shipping/handling).