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FDA | FDA Centennial
Date and Time: The meeting will be held on September 21, 2006,
from 8 a.m. to 5 p.m.
Location: Food and Drug Administration, CDER Advisory Committee
Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD.
Contact Person: Cathy Groupe, 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:
301-827-6778, e-mail: Cathy.Groupe@fda.hhs.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512533 . Please call the information line
for up-to-date information on this meeting.
Agenda : The committee will discuss clinical data for aprotinin
injection (trade name, TRASYLOL), an approved product, new drug application
(NDA) 020-304, Bayer Pharmaceuticals) with the indication for prophylactic use
to reduce perioperative blood loss and the need for blood transfusion in patients
undergoing cardiopulmonary bypass in the course of coronary artery bypass graft
surgery. This discussion follows a February 8, 2006, FDA Public Health Advisory
for the use of aprotinin injection (www.fda.gov/cder/drug/advisory/aprotinin.htm).
The background material
for this meeting will be posted 1 business day before the meeting.
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 on or before September 13, 2006. 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 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 on or before September 13, 2006.
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 John Lauttman at least 7 days in advance of the meeting.