Dear Pain Management
Advocate:
In response to your request
to be informed regarding regulatory and other matters related to pain
management advocacy, the following meeting might be of interest to you and/or
your constituency. The FDA Anesthetic and Life Support
Drugs Advisory Committee has scheduled a meeting to discuss Risk
Management Plans for opiate analgesic drug products with particular attention
to modified-release products. The announcement is listed below for your
reference. The schedule and contact information is as follows:
DATE AND TIME: The
meeting will be held on September 9 and 10, 2003 from
LOCATION: Holiday Inn,
CONTACT: Johanna Clifford, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration,
Telephone: 301-827-7001; Fax: 301-827-6772
Email: clifford@cder.fda.gov
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, Rm.1061,
AGENDA: See attached schedule for the
details of the agenda for each day.
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
For additional information, you can visit the FDA
website at http://www.fda.gov/cder and
click on Advisory Committee. Follow the prompts to the September
Calendar. You may also call the FDA Advisory Committee Information line at
(800) 741-8138 or, in the
Cordially,
Patient Advocacy