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Agency | Date | Time | Location |
---|---|---|---|
FDA | November 5, 2004 | 8 a.m. - 5 p.m. | 5630 Fishers Lane |
Agenda:
The Board will hear about and discuss: (1) An update on the FDA Critical Path
Initiative (http://www.fda.gov/oc/initiatives/criticalpath/),
including an overview of docket submissions, current status, reports on related
activities (Medical Technology Innovation Task Force and Foods Critical Path
White Paper), and future plans; (2) FDA's final report on pharmaceutical current
good manufacturing practices (http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm);
and (3) an internal peer review of the Office of Regulatory Affairs' pesticide
program, including plans for the establishment of a Science Board subcommittee
to conduct an external program peer review.
Background material and meeting information will become available no later than one business day before the meeting (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 29, 2004. Oral presentations from the public will
be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before October 29, 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 Jan Johannessen at least 7 days in advance of the meeting.
Contact Person:
Jan Johannessen, Office of the Commissioner (HF-33), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-827-6687, jjohannessen@fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512603. Please call the Information Line
for up-to-date information on this meeting.