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| Center | Date | Time | Location |
|---|---|---|---|
| CDER | September 9, 2003 September 10, 2003 |
8:00 a.m. - 5:00 p.m. | Holiday Inn |
| *Interested persons and organizations may submit written or electronic comments until October 10, 2003, to the Division of Dockets and Management (see Addresses). | |||
Agenda:
On September 9, 2003, the committee will discuss Risk Management Plans for opiate
analgesic drug products with particular attention to modified-release products.
On September 10, 2003, the committee will discuss the abuse liability of and
Risk Management Plans for Palladone (hydromorphone hydrochloride) Purdue Pharma,
LP, a modified-release hydromorphone drug product indicated for the treatment
of moderate to severe pain in opioid tolerant patients.
Background material will become available no later than the day before the meeting
and will be posted under the Dockets Management Branch site at http://www.fda.gov/ohrms/dockets/ac/03acdocs.htm.
(Scroll down and select the appropriate advisory committee link.)
Addresses:
Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments.
Select "2003N-0294 Opiate Risk Management" and follow the prompts
to submit your statement. Written comments should be submitted to the Dockets
Management Branch, HFA-305, Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
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 by September 2, 2003. Oral presentations from the public will
be scheduled between approximately 1:15 p.m. and 1:45 p.m. on September 9, 2003
and between 11:30 a.m. and 12:00 noon on September 10, 2003. Time allotted for
each presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before September 2, 2003, 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. 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 Angie Whitacre at 301-827-7001 at least 7 days in advance of
the meeting.
Contact Person:
Johanna Clifford, 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 or email: cliffordj@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12529. Please call the Information Line for up-to-date
information on this meeting.
[Full FR Notice] [Amendment to FR Notice]