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:
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!
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 CONTACTSTEVEN WEISMAN, PH.D., HEAD OF CLINICAL AND REGULATORY SUPPORT |
ISS focuses attention on the goal of leading a team to successful interaction with the FDA." - Global Medical Program Director, Novartis
I have always been impressed with ISS's accessible and adaptability to our needs, they are not just a vendor providing a service but a true partner that shares the team's accountability for the outcome." - Project Management Director, Janssen Research and Development
My company has depended on "Scientific Litigation Support" to develop a stronger and more comprehensive understanding of a scientific topic in which we are involved in providing litigation support and/or expert witness work." - President, Counsel in Occupational & Environmental Health, Inc.
