This post was written by Paul Sheives.

A new FDA publication, “Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings,“ is intended to inform the public how they may participate at an open public hearing session of advisory committee meetings. The document addresses the process for speaking and submitting presentations at the open public hearing, and also provides information regarding financial disclosure for participants. The guidance document is directed to general members of the public, individuals or spokespersons from the regulated industry (except the sponsor whose product is under review), consumer advocacy groups, and professional organizations.