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Center | Date | Time | Location |
---|---|---|---|
CDER | October 19, 2004 October 20, 2004 |
8:30 a.m. - 5 p.m. 8:30 a.m. - 5 p.m. |
Food and Drug
Administration |
Agenda:
On October 19, 2004, the committee will do the following: (1) receive updates
pertaining to the Manufacturing Subcommittee, the Parametric Tolerance Interval
Test (PTIT) Workgroup, and the Good Manufacturing Practices (GMPs) for the 21st
Century Initiative, and (2) review and discuss research opportunities under
the Critical Path Initiative.
On October 20, 2004, the committee will do the following: (1) review and discuss the Office of Pharmaceutical Science (OPS) plans and activities designed to take the organization towards the ‘‘desired state’’ of science and risk-based regulatory policies and practices as articulated under the GMPs for the 21st Century Initiative, and (2) review and discuss specific topics related to pharmaceutical equivalence and bioequivalence of generic drugs.
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 12, 2004. Oral presentations from the public will
be scheduled between approximately 1 p.m. and 2 p.m. on both days. Time allotted
for each presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before October 12, 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.