FDA Home | Search FDA Site | A-Z Index | Contact FDA

Advisory Committee for Pharmaceutical Science - Manufacturing Subcommittee

Agenda:
On May 21, 2003, the subcommittee will discuss: (1) The mission of the subcommittee; and (2) direction of the Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century: A Risk-Based Approach.

On May 22, 2003, the subcommittee will discuss: (1) The regulatory approaches regarding aseptic manufacturing; and (2) process analytical technologies and transition from the Advisory Committee for Pharmaceutical Science-Process Analytical Technologies Subcommittee to Manufacturing Subcommittee.

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 13, 2003. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:30 p.m. on both days. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 13, 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 Karen M. Templeton-Somers at least 7 days in advance of the meeting.

Contact Person:
Karen M. Templeton-Somers, 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: somersk@cder.fda.gov or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12539. Please call the Information Line for up-to-date information on this meeting.

[Full FR Notice]