This SAC Tracker report has not been published yet.
The reports are presented in real time:
Within one week of the FDA’s announcement of a meeting date, Tarius publishes the Background Analysis (#1), containing information about the product, its proposed indication and the key issues to be discussed.
When the FDA releases materials concerning a given meeting (normally 1-2 days ahead of the meeting), the Briefing Summary (#2) provides you with a handy abstract of the FDA’s and the Sponsor’s often voluminous briefing materials, supporting your preparations for the upcoming meeting.
Soon after the close of a meeting, the Results Wire (#3) contains an overview of the key outcomes and voting results, when applicable, of the Committee.
The Final Results Wire (#4) is an updated version of the #3 (Results Wire). This document provides the specific comments made by the individual committee members with his or her vote, when applicable.
More than 20% of the time in 2016, the FDA’s decision differed from the Committee’s vote (either entirely or in part). The FDA decisions are typically made 3-4 months after the meeting. The FDA Decision Report (#5) keeps you updated on FDA decisions.
The Background Analysis is available for FREE on this site until 10 days after the meeting is held. The four remaining reports are only available to subscribers. To obtain unlimited access to SAC Tracker meeting reports back to 2010 and onwards, including the committee members' voting history, you must subscribe to the SAC Tracker service.