FDA Releases Draft Guidance on Public Participation in Open FDA Hearings

The FDA has published a new draft guidance that provides recommendations on how the public, including industry representatives, may participate in open public hearing sessions conducted as part of advisory committee meetings.

FDA regulations require that a minimum of 60 minutes of each advisory committee meeting be dedicated to an open hearing session for oral presentations from the public. In order to participate in the session, interested parties should submit a request to the agency with their name, the name of the group he or she represents and a brief mission statement of the group.

Additionally, the agency requires potential speakers to provide a brief description of the presentation and the amount of time requested for the presentation. All of the information should be submitted prior to the deadline date listed in the Federal Register notice announcing the advisory committee meeting, the guidance states.

In addition to providing guidance for presentation requests, the document also includes information about the logistics of giving a presentation at an advisory committee meeting.

To view the draft guidance, "The Open Public Hearing -- FDA Advisory Committee Meetings," go to http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0042-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0042-gdl0001.pdf).