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Drug Safety and Risk Management Advisory Committee
Change in Meeting Start Time
This meeting originally scheduled to start at 8:30 a.m. will start at 8:00 a.m.

Agenda:
This is the first in a series of meetings related to the issues in drug safety and FDA. This 2 day meeting will explore issues related to FDA's risk assessment program for marketed drugs. There are a number of methods that FDA uses in risk assessment of marketed drugs, including review and analysis of spontaneous reports of adverse events, drug use data, healthcare administrative data, epidemiologic and observational studies, clinical trials, and active surveillance systems. Considerations will include the advantages and disadvantages of the current system for safety signal detection, and proposals for short-term and long-term ways to improve the current system.

Background material and meeting information will become available no later than one business day before each meeting day (Simply select the appropriate 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 by May 9, 2005. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon on May 18, 2005, and between approximately 11:10 a.m. and 11:40 a.m. on May 19, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 9, 2005, 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 Shalini Jain at least 7 days in advance of the meeting.

Contact Person:
Shalini Jain, 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, e-mail: jains@cder.fda.gov.

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512535.