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Cardiovascular and Renal Drugs Advisory Committee

Agenda:
On April 25, 2006, the committee will meet between 8 a.m. to 5 p.m., to discuss new drug application (NDA) 21-359 CELLEGESIC (nitroglycerin [NTG] ointment), 0.4% intra-anal, Cellegy Pharmaceuticals, Inc., for the proposed indication of relief of pain associated with anal fissures.

On April 26, 2006, the committee will meet between 8 a.m. to 12 noon, to discuss the agency's draft recommendations for relabeling of antihypertensive drugs for outcome claims, as a followup to the committee's meeting on June 15, 2005, where the committee discussed class labeling of antihypertensive drugs based on the proximity of their data to outcome trials. Following this, from approximately 1 p.m. to 5 p.m., the committee will discuss the "Placebo in Hypertension Adverse Reaction Meta-Analysis" Study, a meta-analysis of more than 80,000 patients in placebo-controlled trials of antihypertensive medications, which evaluated the risk of irreversible harm in conducting placebo-controlled trials in patients with hypertension.

Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).

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 by April 14, 2006. On April 25, 2006, oral presentations from the public will be scheduled between approximately 8:15 a.m. to 8:45 a.m. On April 26, 2006, oral presentations from the public will be scheduled between approximately 8:15 a.m. to 8:45 a.m. and 1 p.m. to 1:30 p.m.. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before April 14, 2006, 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. 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 at 301-827-7001.

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, e-mail: Cathy.Groupe@fda.hhs.gov

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512533.