FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
|CDER||September 9, 2003
September 10, 2003
|8:00 a.m. - 5:00 p.m.||
|*Interested persons and organizations may submit written or electronic comments until October 10, 2003, to the Division of Dockets and Management (see Addresses).|
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.)
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.
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.
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: email@example.com, 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]