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Vaccines and Related Biological Products Advisory Committee

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May 16-17, 2001 Meeting

Date and Time

The meeting will be held on May 16, 2001, 8:00 am to 6:30 pm, and on May 17, 2001, 8:00 am to 1:30 pm.

Location

Holiday Inn, Grand Ballroom, 2 Montgomery Village Avenue, Gaithersburg, MD 20879, 301-948-8900

Contact

Nancy T. Cherry or Denise H. Royster, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138, (301-443-0572 in the Washington, DC area), code 12391. Please call the Information Line for up-to-date information on this meeting.

Agenda

On May 16, 2001, the committee will discuss adventitious agent testing, tumorigenicity testing, and issues related to residual cell substrate DNA of novel and neoplastic cell substrates used to manufacture viral vaccines.

Oral Presentations

On May 16, 2001, between approximately 2:30 and 3:30 pm oral presentations from the public will be scheduled. Those desiring to make oral presentations should notify the contact person before May 8, 2001.

Closed Committee Deliberations

On May 16, 2001, from 8:00 am to 9:00 am, and on May 17, 2001, from 8:00 am to 1:30 pm the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).

 

 
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