Laws, Regulations & Guidance
FDA's advisory committee program is governed by a number of Federal laws and regulations that set forth standards for convening advisory committees and reviewing potential conflicts of interest, among other things. FDA also has developed guidance documents that describe FDA's recommendations and policy related to our advisory committees.
We make these laws, regulations, and guidance documents available through our web site to provide ready access to the statutory and regulatory framework that FDA advisory committees operate within and to describe the steps that FDA has taken to enhance decision making, increase transparency, and strengthen public confidence in our advisory committee program.
For FDAAA, take special note of Section VII of the Act
Public Availability of Advisory Committee Members' Financial Interest Information and Waivers - Final Guidance(PDF - 63KB) Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees - Final Guidance - August 1, 2008(PDF - 106KB) Voting Procedures at Advisory Committee Meetings - Final Guidance - August 1, 2008(PDF - 37KB) Preparation and Public Availability of Information Given to Advisory Committee Members - Final Guidance - August 1, 2008(PDF - 169KB) When FDA Convenes an Advisory Committee - Draft Guidance - August 1, 2008(PDF - 40KB) The Open Public Hearing at FDA Advisory Committee Meetings - Final Guidance(PDF - 54KB)