December 17, 2009: Oncologic Drugs Advisory Committee Meeting Announcement
|CDER||December 17, 2009||8:00 a.m. - 1:00 p.m.||Hilton Washington DC North/Gaithersburg|
620 Perry Parkway
On December 17, 2009, the committee will discuss new drug application (NDA) 022–555, proposed trade name HEXVIX (hexaminolevulinate as hydrochloride) Kit, for the preparation of HEXVIX solution for intravesical use, by Photocure ASA. The product is a diagnostic imaging agent that becomes visible when illuminated by blue light, a special type of light that causes the agent to appear a certain (fluorescent) color. The agent is proposed for administration into the bladder to help in the examination of the bladder wall with a cystoscope, a surgical instrument used to detect some types of cancer. The proposed indication (use) for this product is for blue light cystoscopy performed with the Karl Storz Photodynamic Diagnosis (PDD) system (equipment that produces blue light) as an adjunct to white light cystoscopy in the detection of non-muscle invasive papillary cancer of the bladder.
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 December 9, 2009.
- Oral presentations from the public will be scheduled between approximately 11:00 a.m. and 12:00 noon on December 17th. 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 December 1, 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 December 2, 2009.
- Nicole Vesely
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
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
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 Public Conduct During FDA Advisory Committee Meetings 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).