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U.S. Department of Health and Human Services

Advisory Committees

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July 19, 2011: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

 

Center Date Time Location
CDER July 19, 2011
 
8:00 a.m. to 5:00 p.m. Hilton Washington DC/Silver Spring
The Ballrooms
8727 Colesville Road
Silver Spring, Maryland

Agenda

On July 19, 2011, the committee will discuss new drug application (NDA) 202293 dapagliflozin, manufactured by Bristol-Myers Squibb and AstraZeneca. Dapagliflozin is the first drug in the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Meeting Materials 

FDA intends to make the complete 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 July 5, 2011.
  • Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m., on July 19, 2011. 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 June 24, 2011

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 June 27, 2011.

 
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 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) 796-9001 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).