“There are places where we can bring more consistency potentially to our processes. There are places where we can bring more transparency to the work we do. We know that and we feel that doing so is important to inspiring confidence in the process,” said Dr. Gottlieb.
Those changes are to include:
▸ Revamped guidance identifying more clearly the conditions under which conflict-of-interest waivers are granted.
▸ New guidance specifying when those waivers will be disclosed to the public and what information will be made available.
▸ New guidance specifying when briefing materials used by advisory committees will be made available to the public.
▸ Broader dissemination of advisory committee schedules through mailings to public groups and electronic notifications through FDA listservs and the Web site.
▸ A streamlined approach to the appointment of members to drug-related advisory committees.