Human Drug Advisory Committees

• Transcripts, Contacts, Rosters, and Charters
• CDER Advisory Committee Staff
• List of Advisory Committees and Information Line Numbers
• CDER Tentative Meeting Schedule Ordered By Committee
• 2008 FDA Advisory Committee Calendar Meeting information includes center, date, time and location, agenda, presentation procedures, contact persons, and links to Federal Register notices.
• Federal Register Notices for Upcoming Past FDA Advisory Committee Meetings
• Committe Nomination Information
  • Consumer Representatives
  • FDA Patient Representative Program
  • Industry Representatives
• FDA Advisory Committees

Introduction

Advisory committees provide FDA with independent opinions and recommendations from outside experts on applications to market new drugs, and on FDA policies.  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.  FDA generally follows an advisory committee's recommendation, but is not bound to do so. For more information, please see

• Consumer Update: New Steps to Improve Advisory Committee Processes
• "Advisory Committees: Critical to the FDA's Product Review Process" from FDA Consumer magazine, Jan-Feb, 2004.
• Guidances and Draft Guidances pertaining to advisory committees

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Last Updated: January 2, 2008

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