The U.S. Food and Drug Administration issued final guidance for people who wish to comment during the agency’s advisory committee meetings. The guidance provides instructions on how to request a time to speak and how FDA staff should respond to requests to speak at the meetings.
The FDA encourages participation from all stakeholders in its decision-making process. Every advisory committee meeting includes an open public hearing session, during which interested people may present relevant information or their oral and/or written views.
The guidance finalizes information contained in the 2005 draft guidance titled The Open Public Hearing – FDA Advisory Committee Meetings – Draft Guidance.
Highlights of the guidance include:
Since meetings typically take several months to plan, we are implementing the new guidance starting with meetings held in March 2011.
Advisory committees enhance the FDA’s ability to protect and promote public health by ensuring FDA has access to comments from the public through the public hearing process provided in existing laws and regulations.
Each advisory committee meeting includes a comment period during which 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, societies, or organizations are invited to speak.
Source: FDA Press Release