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Meeting of the Advisory Committee for Reproductive Health Drugs

Center Date Time Location
CDER September 8, 2008 8:00 a.m. - 5:00 p.m. Hilton Washington DC Rockville
Plaza Ballrooms I and II
1750 Rockville Pike
Rockville, MD

Agenda

The committee will discuss new drug application (NDA) 22–242, proposed trade name FABLYN (lasofoxifene tartrate) Tablets, 0.5 milligrams (mg), Pfizer Inc., for the proposed indication of the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Meeting Materials

Meeting Materials

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

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 20, 2008.

Contact Information

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 agencys Web site 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 FDAs Web site after the meeting.

Persons attending FDAs 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 Kalyani Bhatt (301) 8277001 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/oc/advisory/default.htm 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).

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