POSTPONED September 13, 2011: Arthritis Advisory Committee Meeting Announcement
NOTE – Reason for Postponement: The Food and Drug Administration (FDA) is postponing the Arthritis Advisory Committee meeting scheduled for September 13, 2011. This meeting was announced in the Federal Register of July 19, 2011 (76 FR 42715). The postponement is due to the fact that the Agency recently received submissions from some of the investigational new drug (IND) application holders for anti-nerve growth factor (Anti-NGF) antibody drug products that contain large quantities of new information that will require additional time for Agency review prior to the advisory committee meeting. A future meeting date will be announced in the Federal Register at a later date.
|CDER||September 13, 2011 ||8:00 a.m. to 5:30 p.m. ||FDA White Oak Campus |
Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
On September 13, 2011, the committee will discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs. These drugs are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. The committee will be asked to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs, and whether the risk benefit balance for these drugs favors continued development of the drugs as analgesics.
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.
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 August 29, 2011.
- Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 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 August 19, 2011.
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 August 22, 2011.
- Philip A. Bautista, Pharm.D.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area) - follow the prompts to the desired center or product 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.
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 Philip A. Bautista at (301) 796-9001 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).