Document ID: FDA-2012-N-0001-0066
Agency: fda
Document Type: Notice
Title: Gastrointestinal Drugs Advisory Committee Meeting; Cancellation
Posted Date: 2012-05-08T04:00Z

[Federal Register Volume 77, Number 89 (Tuesday, May 8, 2012)]
[Notices]
[Page 27072]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10990]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Gastrointestinal Drugs Advisory Committee; Cancellation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The meeting of the Gastrointestinal Drugs Advisory Committee 
scheduled for May 31, 2012, is canceled. This meeting was announced in 
the Federal Register of March 23, 2012 (77 FR 17078). The meeting is 
being canceled because the Agency no longer needs to discuss the issues 
that were originally under consideration in the review of the 
application. The sponsor of the new drug application (NDA) submitted 
new information which negated the necessity for the planned meeting. 
The Agency intends to continue evaluating NDA 200-436 and, as needed, 
may schedule an Advisory Committee meeting in the future.

FOR FURTHER INFORMATION CONTACT: Minh Doan, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 
301-847-8533, email: GIDAC@fda.hhs.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), to find out further information regarding FDA advisory committee 
information or visit our Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: May 2, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-10990 Filed 5-7-12; 8:45 am]
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