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  4. June 28, 2016: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee - 06/27/2016 - 06/27/2016
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Advisory Committee Meeting

Event Title
June 28, 2016: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee
June 27, 2016


Date:
June 27, 2016
Time:
08:00 PM - 08:00 PM EDT

UPDATED WEBCAST INFORMATION: June 28, 2016: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Updated Information (as of 5/23/2016):
The webcast information portion of this announcement was published in error. The following change has been made:

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 June 28, 2016 Endocrinologic and Metabolic Advisory Committee meeting.

Additionally, the information on Public Meetings at the FDA White Oak Campus has been removed.

All other information remains the same.

Center
CDER 

Date 
June 28, 2016

Time
8:00 a.m. to 5:00 p.m.  

Location
Hilton Washington DC/Rockville
Hotel & Executive Meeting Center Plaza Ballroom
1750 Rockville Pike
Rockville, MD 20852

Agenda

The committee will discuss supplemental new drug application (sNDA) 204629 for empagliflozin (JARDIANCE) tablets and sNDA 206111 for empagliflozin and metformin hydrochloride (SYNJARDY) tablets. Both sNDAs are sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed additional indication in adult patients with type 2 diabetes mellitus and high cardiovascular risk to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death and to reduce the risk of cardiovascular death or hospitalization for heart failure.

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 is available at: Advisory Committee Calendar

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

June 14, 2016.

  • Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 p.m. on June 28, 2016. Those individuals interested in making 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 6, 2016.

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 7, 2016.

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 June 28, 2016 Endocrinologic and Metabolic Drugs Advisory Committee meeting.

Contact Information     

  • LaToya Bonner, PharmD
    Center for Drug Evaluation and Research
    Food and Drug Administration
    10903 New Hampshire Avenue
    WO31-2417
    Silver Spring, MD 20993-0002

    Phone: 301-796-9001
    Fax: 301-847-8533
    Email:  EMDAC@fda.hhs.gov

  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC 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 Web site 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 disabilities. If you require accommodations due to a disability, please contact LaToya 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).

 

FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC 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 Web site 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 disabilities. If you require accommodations due to a disability, please contact Lauren Tesh at (301) 796-9001 at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

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).