Document ID: FDA-2014-N-0001-0077
Agency: fda
Document Type: Notice
Title: Joint Meeting of the Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory
Committee; Amendment of Notice
Posted Date: 2014-09-12T04:00Z

[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Notices]
[Page 54730]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21780]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee 
and the Drug Safety and Risk Management Advisory Committee; Amendment 
of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Joint Meeting of the 
Psychopharmacologic Drugs Advisory Committee and the Drug Safety and 
Risk Management Advisory Committee. This meeting was announced in the 
Federal Register of April 25, 2014 (79 FR 22995). The amendment is 
being made to reflect a change in the Agenda portion of the document. 
There are no other changes.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, 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: PDAC@fda.hhs.gov, or 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.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 25, 2014, 
FDA announced that a meeting of the Joint Meeting of the 
Psychopharmacologic Drugs Advisory Committee and the Drug Safety and 
Risk Management Advisory Committee would be held on October 16, 2014. 
On page 22996, in the first column, the Agenda portion of the document 
is changed to read as follows:
    Agenda: The committees will discuss safety data from observational 
studies and a meta-analysis of randomized controlled clinical trials 
that have been conducted since the original signal of serious 
neuropsychiatric adverse events with CHANTIX (varenicline tartrate 
tablets, NDA 21928, Pfizer, Inc.) emerged. The committees will also 
discuss whether any action needs to be taken with regard to how this 
risk is described in product labeling.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: September 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21780 Filed 9-11-14; 8:45 am]
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