New Policies and Procedures Regarding Transparency and Public Disclosure for FDA Advisory Committees

Topics on this Page

• Introduction
• New Guidance Documents
• News Release
• More on Advisory Committee Improvements

Introduction

The Food and Drug Administration has announced several new policies and procedures to strengthen its management of FDA advisory committees. They are detailed in four final guidance documents and one draft guidance. Our goal is to make our process for seeking advice from independent experts as open, public, and transparent as possible, so that we maintain the highest public confidence in that process.

New Guidance Documents

• Final Guidance on Procedures For Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees - 
  How you can comment
• Final Guidance on Public Availability of Advisory Committee Members' Financial Interest Information and Waivers - 
  How you can comment
• Final Guidance on Voting Procedures at Advisory Committee Meetings - 
  How you can comment
• Final Guidance on Preparation and Public Availability of Information Given to Advisory Committee Members - 
  How you can comment
• Draft Guidance on When FDA Convenes an Advisory Committee - 
  How you can comment

News Release

• FDA Announces New Policies To Improve Transparency, Public Disclosure Regarding Advisory Committees

More on Advisory Committee Improvements

• Fact Sheet
• Consumer Article: Strengthening the Advisory Committee Process