July 15, 2009: Oncologic Drugs Advisory Committee Meeting Announcement
Center Date Time Location
CDER July 15, 2009 8:00 a.m. - 5:00 p.m. Hilton Washington DC
North/Gaithersburg
The Ballrooms
620 Perry Pkwy
Gaithersburg, MD
Agenda
On July 15, 2009, the committee will discuss (1) new drug application (NDA) 022-447, proposed trade name YONDELIS (trabectedin) powder, for concentrate for solution for intravenous infusion, Centocor Ortho Biotech Products, L.P., proposed indication in combination with DOXCIL (doxorubicin HCl liposome injection), for the treatment of patients with relapsed ovarian cancer; and (2) supplemental new drug application (sNDA) 050-718/S-039, DOXIL (doxorubicin HCl liposome injection), for intravenous infusion, Centocor Ortho Biotech Products, L.P., proposed indication in combination with docetaxel for the treatment of patients with locally advanced or metasatic breast cancer who have received prior anthracycline treatment.
Meeting Materials
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Background material
Public Participation Information
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 June 30, 2009
Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11:00 a.m., and 3:30 p.m. to 4 p.m. 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 June 22, 2009.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 23, 2009.
Contact Information
Nicole Vesely
Center for Drug Evaluation and Research (HFD-21)
Food and Drug Administration
5600 Fishers Lane (for express delivery, Fishers Lane, rm. 1093)
Rockville, MD 20857
Phone: 301-827-7001
Fax: 301-827-6776
E-mail: Nicole.vesely@fda.hhs.gov
FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)
Code: 3014512542
Please call the Information Line for up-to-date information on this meeting.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
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 Nicole Vesely at (301) 827-7001 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings.
Please visit our Web site at
http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).
