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Advisory Committee for Pharmaceutical Science

Agenda:
On May 3, 2005, the committee will: (1) Receive an update from the Clinical Pharmacology Subcommittee and (2) discuss and provide comments on the general topic of establishing drug release or dissolution specifications.

On May 4, 2005, the committee will: (1) Receive an update on current activities of the Parametric Tolerance Interval Test Workgroup, (2) discuss and provide comments on the general topic of considerations for assessment of pharmaceutical equivalence and product design, and (3) discuss criteria for establishing a working group for review and assessment of Office of Pharmaceutical Science research programs.

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 April 25, 2005. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 p.m. each day. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before April 25, 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 Hilda Scharen, at least 7 days in advance of the meeting.

Contact Person:
Hilda Scharen, 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, email: scharenh@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512539. Please call the Information Line for up-to-date information on this meeting.