Advisory Committees

April 1, 2014: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

UPDATED WEBCAST INFORMATION: April 1, 2014: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Updated Information (as of 3/14/2014):

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 April 1, 2014 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.

CenterDateTimeLocation
CDERApril 1, 20148:00 a.m. to 5:00 p.m.The Marriott Inn and Conference Center
University of Maryland University
College (UMUC), Potomac Ballroom
3501 University Blvd. East
Hyattsville, Maryland

Agenda

The committee will discuss new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), 3 unit and 6 unit cartridges for oral inhalation, manufactured by MannKind Corporation. The proposed indication (use) for this application is to improve glycemic control in adult patients with type 1 or 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./p>

  • Written submissions may be made to the contact person on or before March 18, 2014.
  • Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m. on April 1, 2014. 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 March 10, 2014.

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 March 11, 2014.

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 April 1, 2014 Endocrinologic and Metabolic Advisory Committee meeting.

Contact Information

  • Karen Abraham-Burrell, PharmD
    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 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Karen Abraham-Burrell 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).

 

Page Last Updated: 12/11/2014
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