FDA Advisory Committees
Tarius’ regulatory experts in the Washington, DC, area continuously monitor the FDA’s scientific advisory committees (SAC’s) to create reports and compile analyses that enable you to stay updated about CBER, CDER and Office of the Commissioner committees.
SAC Members’ Biographies and Voting Histories
Tarius has compiled extensive background information and voting records on each current committee member, per question, for all meetings from 2010 to the present. All information is organized by name and committee, and is full-text searchable.
#1: Background Analysis
Within one week of the FDA’s announcement of a meeting date, Tarius publishes the Background Analysis. This report contains: a brief agenda, information about the proposed treatment/approved treatment to be discussed (such as its formulation and administration), information for other products in the same drug class, known safety issues for the product or drug class, information about the disease area, clinical trial information for the product and the regulatory background.
The Background Analysis will help you determine the relevance for your organization of a particular meeting.
#2: Briefing Summary
On the day the FDA releases materials ahead of a given meeting, the Briefing Summary provides a concise abstract of the often voluminous briefing materials by the FDA and the sponsor to facilitate your preparations for the upcoming meeting.
#3: Results Wire
Soon after the close of a meeting, the Results Wire contains an overview of the key outcomes and voting results, when applicable, of the committee.
#4: Final Results Wire
The Final Results Wire is an updated version of #3 (Results Wire). This document provides the specific comments made by the individual committee members with his or her vote, when applicable.
#5: FDA Decision Report
More than 20% of the time in 2016, the FDA’s decision differered from the Committee’s vote (either entirely or in part). The FDA Decision Report keeps you updated on the FDA’s decisions and informs you about whether the decisions are aligned or are different from the Committee’s recommendations. This report also provides information about product labeling and postmarket requirements, when applicable. The FDA’s decisions are typically made 3-4 months after the meeting.
#5 reports for voting Committee meetings from 2014 to present are available.