Guidance for Industry: Advisory Committee Meetings-Preparation and Public Availability of Information Given to Advisory Committee Members; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Advisory Committee Meetings--Preparation and Public Availability of Information Given to Advisory Committee Members," dated August 2008. This document provides guidance to industry sponsors, applicants, and petitioners who develop, prepare, or submit briefing materials that will be given to advisory committee members as background information before an open FDA advisory committee meeting. The guidance announced in this notice finalizes the draft guidance of the same title dated February 2007. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of three additional guidances and one draft guidance, intended to improve FDA's advisory committee procedures.