Advisory Committees
November 8, 2012: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
UPDATED LOCATION, PUBLIC PARTICIPATION INFORMATION, AND WEBCAST INFORMATION: November 8, 2012: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Updated Information (as of 10/12/2012):
The location for this meeting has changed from the DoubleTree by Hilton Hotel Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Road, Silver Spring, Maryland to FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, Maryland. Additionally, written submissions may be made to the contact person on or before November 2, 2012, individuals interested in making formal oral presentations should notify the contact person on or before October 25, 2012, and that the contact person will notify interested persons regarding their request to speak by October 26, 2012. Also, CDER now plans to provide a free of charge, live webcast of the meeting. All other information remains the same.
Center | Date | Time | Location |
---|---|---|---|
CDER | November 8, 2012 | 8:00 a.m. - 5:00 p.m. | FDA White Oak Campus Building 31 Great Room (Rm. 1503) White Oak Conference Center 10903 New Hampshire Avenue Silver Spring, Maryland |
Information regarding ground transportation, airport information, lodging, driving directions and visitor parking, and security can be accessed at: Public Meetings at the FDA White Oak Campus.
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 November 2, 2012.
- Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. 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 October 25, 2012.
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 October 26, 2012.
Webcast Information
CDER plans to provide a free of charge, live webcast of the November 8, 2012, meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
ORIGINAL INFORMATION
Center | Date | Time | Location |
---|---|---|---|
CDER | November 8, 2012 | 8:00 a.m. to 5:00 p.m. | DoubleTree by Hilton Hotel Washington DC - Silver Spring The Ballrooms 8727 Colesville Road Silver Spring, Maryland |
- Written submissions may be made to the contact person on or before October 24, 2012.
- Oral presentations from the public will be scheduled between approximately 1 p.m. – 2 p.m. on November 8, 2012. 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 October 16, 2012.
- Paul Tran, R.Ph.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993
Phone: 301-796-9001
Fax: 301-847-8533
E-mail: EMDAC@fda.hhs.gov
- FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)- follow the prompts to the desired center or product area
Please call the Information Line for up-to-date information on this meeting.