Document ID: FDA-2010-N-0001-0039
Agency: fda
Document Type: Notice
Title: Meetings: Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment
Posted Date: 2010-04-06T04:00Z

[Federal Register: April 6, 2010 (Volume 75, Number 65)]
[Notices]               
[Page 17417]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ap10-65]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Joint Meeting of the Arthritis 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 a joint meeting of the Arthritis Advisory 
Committee and the Drug Safety and Risk Management Advisory Committee. 
This meeting was announced in the Federal Register of March 8, 2010 (75 
FR 10490). 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: Anuja Patel, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), 
Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: 
Anuja.Patel@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington DC area), codes 3014512532 
and 3014512535. Please call the Information Line for up-to-date 
information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 8, 2010, 
FDA announced that a joint meeting of the Arthritis Advisory Committee 
and the Drug Safety and Risk Management Advisory Committee would be 
held on May 12, 2010. On page 10490, in the second column, the Agenda 
portion of the document is changed to read as follows:
    Agenda: The committees will discuss new drug application (NDA) 22-
478, naproxcinod 375 milligram capsule, sponsored by NicOx S.A. 
Naproxcinod is a non-steroidal anti-inflammatory drug (NSAID) product 
indicated for the treatment of the signs and symptoms of 
osteoarthritis.
    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: April 1, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-7697 Filed 4-5-10; 8:45 am]
BILLING CODE 4160-01-S