Kickas.org Forums Ankylosing Spondylitis General Discussion Highlights in Spondylitis Research FDA Arthritis Advisory Committee Meeting 3/12/12

MEETING: Federal Register - Food and Drug Administration (FDA)—Jan 11, 2012

Date and Time: The meeting will be held on March 12, 2012, from 8 a.m. to 5:30 p.m. The meeting will be open to the public.Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room, (rm. 1503), Silver Spring, MD 20993-0002...

Contact Person: Philip A. Bautista, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, (301) 796-9001, FAX: (301) 847-8533, email: AAC@fda.hhs.gov , or FDA Advisory Committee Information Line, 1-(800) 741-8138 ((301) 443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting...

Agenda: 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. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm .