FDA Advisory Committee Meeting to Review Egrifta
The Food and Drug Administration (FDA) will hold a public meeting of its Endocrinologic and Metabolic Drugs Advisory Committee to discuss the safety and efficacy of new drug application (NDA) 22–505, EGRIFTA (tesamorelin acetate), sterile lyophilized powder for injection, by Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a reduction of excess visceral abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy (a condition in which abnormal deposits of fat are seen partly as a result of using certain drugs to treat HIV disease).
The meeting will take place on May 27, 2010, from 8 a.m. to 5 p.m, at The Inn and Conference Center, University of Maryland University College (UMUC), 3501 University Blvd. East, Adelphi, MD. You can contact the hotel directly at 301–985– 7300 for directions or to arrange accommodations.
The meeting will be open to the public, and no registration is required.
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Written submissions may be made to Paul Tran, 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, FAX: 301– 827–6776, e-mail: firstname.lastname@example.org on or before May 13, 2010.
Oral presentations from the public (the open public hearing) will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify Paul Tran, 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 May 5, 2010.
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.
Those requesting time to present will be notified regarding their request to speak by May 6, 2010.
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 can be found at http://www.fda.gov/AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link.
Please call the FDA Advisory Committee Information Line for up-to-date information about this meeting, at 1–800–741–8138 (301–443–0572 in the Washington, DC area), and use code 3014512536. 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 Web site 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 Paul Tran 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/ AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.
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Food and Drug Administration
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Food and Drug Administration