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Human Drug Advisory Committees
- 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
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2004 Tentative Meeting Schedule Ordered By Committee
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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.
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Federal
Register Notices of Past FDA Advisory Committee Meetings
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Committee Nomination Information for Consumer, Patient, and Industry Representatives
- Other FDA
Advisory Committees
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Introduction
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:
Some documents on this web site are in Adobe Acrobat format
, also known as PDF. A free copy of Adobe Acrobat Reader 5.0 can be
downloaded.
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Last Updated: October 26, 2004 |
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