Document ID: FDA-2008-N-0026-0001
Agency: fda
Document Type: Notice
Title: Drug Safety and Risk Management Advisory Committee; Amendment of Notice
Posted Date: 2008-01-15T05:00Z

[Federal Register: January 15, 2008 (Volume 73, Number 10)]
[Notices]               
[Page 2509]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja08-73]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Drug Safety and Risk Management Advisory Committee; Amendment of 
Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of meeting of the Drug Safety and Risk Management 
Advisory Committee. This meeting was announced in the Federal Register 
of December 11, 2007 (72 FR 70336). 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: Teresa A. Watkins, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-
mail: Teresa.Watkins@fda.hhs.gov, or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington DC area), code 
3014512535. Please call the Information Line for up-to-date information 
on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 11, 
2007, FDA announced that a meeting of the Drug Safety and Risk 
Management Advisory Committee would be held on February 1, 2008. On 
page 70336, in the second column, the first paragraph of the Agenda 
portion of document is amended to read as follows:
    Agenda: The committee will discuss the efficacy and safety of new 
drug application (NDA) 22-054, INJECTAFER (ferric carboxymaltose 
injection), Luitpold Pharmaceuticals Inc., used for the treatment of 
iron deficiency anemia in postpartum patients or iron deficiency anemia 
in patients with heavy uterine bleeding.
    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: January 7, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-490 Filed 1-14-08; 8:45 am]

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