Advisory Committees

CDER uses advisory committees to obtain outside advice and opinions from expert advisors so that final agency decisions will have the benefit of wider national expert input. Committee recommendations are not binding on CDER, but the agency considers them carefully when deciding drug issues.

CDER may especially want a committee's opinion about a new drug, a major indication for an already approved drug, or a special regulatory requirement being considered, such as a boxed warning in a drug's labeling. Committees may also advise CDER on necessary labeling information, or help with guidelines for developing particular kinds of drugs. They may also consider questions such as whether a proposed study for an experimental drug should be conducted or whether the safety and effectiveness information submitted for a new drug are adequate for marketing approval.

For additional information about FDA advisory committee meetings, call 1-800-741-8138. In the metropolitan Washington, D.C. area, call (301)443-0572.