Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings." We are issuing the guidance to provide information on how the public may participate at the open public hearing (OPH) portion of FDA advisory committee meetings. The guidance also provides recommendations regarding financial disclosure by persons participating in the OPH portion of advisory committee meetings.