FDA Advisory Committee Meeting Toolbox

With millions of dollars at stake and only one shot to influence the outcome, you need ISS and our FDA Advisory Committee Toolbox to help you prepare. Our proven strategies give you the power to put your best data forward.

Here you will find tools and resources to help you better understand the FDA Advisory Committee review process, prepare for an upcoming meeting, and stay abreast of the latest updates from the FDA.

Get Smart

The FDA Advisory Committee review process is very stressful. Thankfully, ISS has developed a program that can be adjusted to fit any timeline, works across therapeutic categories, and ensures success every time:

ISS' Pharmaceutical & Medical Device Advisory Committee Meeting Preparation & Management Webinar Series:

The preparation and management of an advisory committee meeting is one of the most important events in the life cycle of the product and needs to be approached as such. Teams may not realize that it takes more than simply being knowledgeable about the science; it also takes STRATEGY, KEY MESSAGING… INTELLIGENCE… and a lot of PRACTICE to appropriately communicate to the committee the benefits of a product and what it provides to public health.Click on the boxes below to receive the slides from our informative webinar series, hosted in conjunction with Q1 Productions, on the nuts and bolts of preparing for and implementing a successful FDA Advisory Committee meeting program!

  • Course 1

  • Course 2

  • Course 3

  • Course 4

Explore

More FDA Advisory Committee Insights from ISS…

 

Download ISS’ Roadmap
to Advisory Committee Meeting Success!

Not every Advisory Committee results in a favorable outcome. But what is the impact of a “negative” Advisory Committee meeting?

Download our analysis of recent FDA Advisory Committee meetings that concluded with unfavorable committee votes, and see what we found!

 

FOR MORE INFORMATION CONTACT

STEVEN WEISMAN, PH.D., HEAD OF CLINICAL AND REGULATORY SUPPORT