Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee
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Center |
Date |
Time |
Location |
CDER |
October 21, 2008
|
8:00 a.m. – 5:00 p.m.
|
Crowne Plaza Hotel
Washington DC-Silver Spring
8777 Georgia Ave.,
Silver Spring, MD
(301) 589-0800
|
Agenda
On October 21, 2008, the committee will begin with a closed session from 8 a.m. to 11 a.m. Following the closed session, from 11 a.m. to 5 p.m., the meeting will be open to the public. The committee will discuss the safety and efficacy of biologic license application (BLA) 125291, MYOZYME (algucosidase alfa) Genzyme Corporation, for the treatment of late onset Pompe disease.
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/ohrms/dockets/ac/acmenu.htm, click on year 2008 and scroll down to the appropriate advisory committee link.
Meeting Materials
Links to meeting materials will be added as they become available.
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
October 6, 2008.
- Oral presentations from the public will be scheduled between approximately
2 p.m. and 3 p.m., October 21, 2006. 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 September 26, 2008.
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 September 29, 2008.
Contact Information
- FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)
Code: 3014512536
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.
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.
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 (301) 827-7001 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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Date created: September 23, 2008 |