Comité consultatif FDA pour Naproxcinod le 12 mai

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA2010N0001]
Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and
Risk Management Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.

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: Arthritis 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 May 12, 2010, from 8 a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville
Rd., Silver Spring, MD. The hotel phone number is 3015895200.
Contact Person: Anuja Patel, Center for Drug Evaluation and Research (HFD21),
Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630
Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001, FAX: 3018276776, email:
Anuja.Patel@fda.hhs.gov, or FDA Advisory Committee Information Line,
18007418138 (3014430572 in the Washington, DC area), codes 3014512532 and
304512535. 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 May 12, 2010, the committees will discuss new drug application (NDA)
22478, naproxcinod0 375 milligram capsule, sponsored by NicOx S.A., a nonsteroidal
anti-inflammatory drug (NSAID) product indicated for the treatment of
the signs and symptoms of osteoarthritis.
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 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/Advisory&fxsp0;Committees/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 April 28, 2010. Oral presentations from
the public will be scheduled between approximately 1 p.m. and 2 p.m. 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 April 20, 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 April 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 Anuja Patel 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/Advisory&fxsp0;Committees/About&fxsp0;Advisory&fxsp0;Committe
es/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: March 2, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 10????? Filed ????10; 8 am]BILLING CODE 416001S
[FR Doc. 2010-4813 Filed 03/05/2010 at 8:45 am; Publication Date: 03/08/2010]

http://www.federalregister.gov/OFRUpload/OFRData/2010-04813_PI.pdf