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Meeting Notice
Amended
Changes in the Agenda and Location portions
of the meeting.
Center | Date | Time | Location |
---|---|---|---|
CDER | November 3, 2004 November 4, 2004 |
8 a.m. - 5:30 p.m. 8 a.m. - 1:30 p.m. |
Center for Drug
Evaluation and Research |
Agenda:
On November 3, 2004, the subcommittee will: (1) Receive topic updates for ongoing
FDA activities previously presented to the subcommittee; (2) discuss and provide
comments on the evidence for updating labels of approved drugs to include integrating
pharmacogenetic, pharmacokinetic, and prognostic biomarkers for the purpose
of optimizing therapeutic response and reducing risks of toxicity; and (3) discuss
and provide comments on metabolism- and transporter-based drug-drug interactions
included as recommendations in a draft guidance for industry being prepared
by FDA.
On November 4, 2004, the subcommittee will discuss and provide comments on a new critical path project related to general aspects of the transition of biomarkers to surrogate endpoints, with a focus on planning and process, rather than on specific biomarkers or surrogate endpoints.
Background material and meeting information will become available no later than one business day before each meeting day (Simply select the appropriate committee link).
Procedure:
Interested persons may present data, information, or views, orally or in writing,
on issues pending before the committee. Written submissions may be made to the
contact person by October 5, 2004. Oral presentations from the public will be
scheduled between approximately 12:30 p.m. and 1 p.m. on November 3, 2004, and
between 1 p.m. and 1:30 p.m. on November 4, 2004. Time allotted
for each presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before October 5, 2004, and submit a brief
statement of the general nature of the evidence or arguments they wish to present,
the names and addresses of proposed participants, and an indication of the approximate
time requested to make their presentation. Persons attending FDA's advisory
committee meetings are advised that the agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings
and will make every effort to accommodate persons with physical disabilities
or special needs. If you require special accommodations due to a disability,
please contact Hilda Scharen at least 7 days in advance of the meeting.
Contact Person:
Hilda Scharen, Center for Drug Evaluation and Research (HFD-21), Food and Drug
Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane,
Rm. 1093), Rockville, MD 20857, 301-827-7001, FAX 301-827-6776, e-mail: scharenh@cder.fda.gov
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512539. Please call the Information Line
for up-to-date information on this meeting.