Human Drug Advisory Committees

Introduction

Introduction
Advisory Committee Meeting Transcripts and Other Meeting Documents, Contacts, Rosters, and Charters (10/28/2004)
CDER Advisory Committee Staff
Calendar of CDER Advisory Committee Meetings
List of Advisory Committees and Information Line Numbers
2004 Tentative Meeting Schedule Ordered By Committee
2004 FDA Advisory Committee Calendar Meeting information includes center, date, time and location; agenda, presentation procedures, contact persons, and links to the Federal Register notice.
Federal Register Notices of Past FDA Advisory Committee Meetings
Committee Nomination Information for Consumer, Patient, and Industry Representatives
Other FDA Advisory Committees

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FDA/Center for Drug Evaluation and Research

Advisory committees provide FDA with independent opinions and recommendations from outside experts on applications to market new drugs, and on FDA policies. Advisory committees schedule meetings to consider the applications and reviews for drugs in specialized medical areas, such as cancer or heart disease. FDA staff members who serves as executive secretaries provide administrative support to each advisory committee, which includes a Chair, several members, plus a consumer and patient representative. For more information on consumer and patient participation in advisory committee meetings, please see the FDA Consumer magazine article, "Advisory Committees: FDA's Primary Stakeholders Have a Say." Additional experts with special knowledge may be added to individual meetings as needed.

The marketing applications include data to show the safety and effectiveness of human drugs. The outside experts receive summary information about the applications and copies of FDA's review of the application documents. Based on this information, advisory committees may recommend approval or disapproval of a drug's marketing application. They may also ask for more information before they can make a recommendation. FDA generally follows an advisory committee's recommendation, but is not bound to do so.

Advisory committee meetings are scheduled a year in advance, from October through September. A scheduled meeting may be cancelled if no marketing applications are ready for review by the scheduled date. Meetings may be added to the schedule if a marketing application is ready for review between scheduled meetings. All meetings must be announced in advance in the Federal Register.

The draft guidance document "Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs" provides guidance to the sponsors of applications that are the subjects of open advisory committee meetings. The draft guidance " Disclosure of Conflicts of Interest
for Special Government Employees Participating in FDA Product Specific Advisory Committees" provides information on the type and amount of information that will be disclosed to the public when a special Government employee (SGE) is granted a waiver for a conflict of interest with the topic to be discussed by the advisory committee that the SGE is attending.

For more information on advisory committees, please see:

"Advisory Committees: Critical to the FDA's Product Review Process." from FDA Consumer magazine, Jan-Feb, 2004.
"Getting Outside Advice for Close Calls" from FDA's special report: From Test Tube to Patient: Improving Health Through Human Drugs.
The guidance document "Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997" provides more detailed information on membership.

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Last Updated: October 26, 2004