The FDA Advisory Committee Survival Manual, 2nd Edition

Publisher

Product Description

RAPS has teamed up with 3D Communications to offer The FDA Advisory Committee Survival Manual, 2nd Edition, an expanded step-by-step guide designed to help pharma, biotech, and medical device companies prepare for, and succeed at, US Food and Drug Administration (FDA) advisory committee meetings (ADCOMs).

The second edition outlines the pragmatic approach and processes that 3D Communications has developed and refined from nearly 500 ADCOMs over more than 20 years.

The book is organized into practical sections that walk readers through every phase of the ADCOM preparation process – addressing the biggest challenges sponsors face in achieving a successful ADCOM. These include: how to analyze the issues that matter to advisory committee members; how to assemble the right sponsor team; how to transform volumes of data into compelling messages and simple slides; how to answer challenging questions from committee members; and how to leverage technology throughout the preparation process and on the day of the ADCOM.

The second edition includes updated content on virtual and hybrid meetings, new templates and tools like the Key Message Grid and Objection Handler, and new chapters on engaging important stakeholders and conducting thorough quality control of data and slides.

Each chapter includes a "how-to" section with actionable tips and key takeaways, making it an invaluable resource for navigating the process with confidence and success.

Who should buy this book?

Special Thanks to 3D Communications

Related book you may be interested in:

• The CHMP Meeting Survival Manual – A Step-by-Step Guide to Succeeding at Regulatory Meetings for Marketing Authorization