What is an FDA advisory committee meeting?

The FDA may require an advisory committee meeting as part of the regulatory review process for certain drugs or indications. The advisory committee meeting consists of members of the FDA, representatives from the sponsor (pharma company), and experts chosen by the FDA (including clinicians, statisticians, etc.) Patient advocates may also be part of the process. Every drug or indication under review does not have an advisory committee. Rather, the FDA decides to schedule them mostly based on their own need for further advice from external experts. FDA advisory committees are public meetings and broadcast online for the public to view. Upcoming meetings can be seen on a calendar on the FDA’s website.