News release: “The U.S. Food and Drug Administration today announced draft guidance that would expand transparency and disclosure when the agency grants a conflict of interest waiver to permit an individual’s participation at an FDA advisory committee meeting. The draft guidance would expand the information disclosed about waivers prior to committee meetings. Specifically, the FDA proposes to post online the name of the company or institution associated with the financial interest along with the type of conflict of interest. Scientific advisory committees provide expert advice on significant scientific, technical, and policy matters to assist in the FDA’s mission to protect and promote the public health. The committees provide advice on specific regulatory decisions, such as product approvals, and general policy matters, including regulations and guidance.”

• Draft Revised Guidance on Transparency and Advisory Committee
• Commissioner Hamburg’s Letter to senior FDA officials on proposed guidance
• Additional Advisory Committee Guidance Documents