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U.S. Department of Health and Human Services

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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.

 

CenterDateTimeLocation
CDERNovember 8, 20128:00 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

CenterDateTimeLocation
CDERNovember 8, 20128:00 a.m. to 5:00 p.m.DoubleTree by Hilton Hotel
Washington DC - Silver Spring
The Ballrooms
8727 Colesville Road
Silver Spring, Maryland

  
Agenda
On November 8, 2012, the committee will discuss the safety and efficacy of new drug applications (NDAs) 203313, insulin degludec/insulin aspart [rDNA origin] injection and 203314, insulin degludec [rDNA origin] injection, manufactured by Novo Nordisk Inc. The proposed indication (use) for these applications is for the treatment of Type 1 and Type 2 diabetes mellitus.
 
Meeting Materials
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
 
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 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.
 
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 17, 2012.
 
Webcast Information
CDER does not provide webcasts of advisory committee meetings that are held at venues other than the FDA White Oak Conference Center. Therefore, CDER will not be providing a webcast of the November 8, 2012 Endocrinologic and Metabolic Drugs Advisory Committee meeting.
 
Contact Information
  • 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.
 
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 FDA Advisory Committee Information 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 (301) 796-9001 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 Public Conduct During FDA Advisory Committee Meetings 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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