Document ID: FDA-2010-N-0001-0061
Agency: fda
Document Type: Notice
Title: Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee
Posted Date: 2010-06-07T04:00Z

[Federal Register: June 7, 2010 (Volume 75, Number 108)]
[Notices]               
[Page 32189-32190]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn10-45]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

 
Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory 
Committee and the Drug Safety and Risk Management Advisory Committee; 
Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committees: Endocrinologic and Metabolic Drugs Advisory 
Committee and the Drug Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 13, 2010, from 8 
a.m. to 6 p.m. and on July 14, 2010, from 8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301-
977-8900.
    Contact Person: Paul Tran, c/o Melanie Whelan, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6100, Silver 
Spring, MD 20993-0002, FAX: 301-847-8737, to reach by telephone before 
June 8, 2010, please call 301-827-7001; to reach by telephone after 
June 8, 2010, please call 301-796-9001, e-mail: paul.tran@fda.hhs.gov, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), codes 3014512536 and 3014512535. 
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 appropriate advisory committee hot line/phone line to learn 
about possible modifications before coming to the meeting.
    Agenda: On both days, the committees will focus primarily on the 
cardiovascular safety of AVANDIA (rosiglitazone maleate) Tablets, 
GlaxoSmithKline, a drug approved for blood glucose control in adults 
with type 2 diabetes mellitus. Data specific to rosiglitazone to be 
presented will include results from the Rosiglitazone Evaluated for 
Cardiac Outcome and Regulation of Glycemia in Diabetes (RECORD) Trial, 
observational data, health claims data, and a meta-analysis of 
controlled clinical trials. In addition, the FDA will present its meta-
analysis of several trials of ACTOS (pioglitazone hydrochloride) 
Tablets, Takeda Pharmaceuticals North America, Inc., another 
thiazolidinedione for the same indication, in response to public 
documents comparing the safety of rosiglitazone to pioglitazone based 
on different meta-analyses performed on each of these two drugs.
    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

[[Page 32190]]

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 http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: 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 
28, 2010. Oral presentations from the public will be scheduled between 
approximately 8:15 a.m. and 9:15 a.m. on July 14, 2010. 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 18, 2010. 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 21, 2010.
    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 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 http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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).

    Dated: June 2, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-13533 Filed 6-4-10; 8:45 am]
BILLING CODE 4160-01-S