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Vaccines and Related Biological Products Advisory Committee

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November 16 - 17, 2005 Meeting

Date and Time:

The meeting will be held on November 16, 2005, 8:30 a.m. to 5:15 p.m.; and on November 17, 2005, 8:30 a.m. to 5:30 p.m.

Location:

Holiday Inn Select, 8120 Wisconsin Avenue, Bethesda, MD, 20814, 301-652-2000 .

Contact Persons:

Christine Walsh, R.N. or Denise Royster, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting.

Agenda:

On November 16, 2005, the Committee will hear presentations and discuss the use of MDCK Cells for manufacture of Inactivated Influenza Vaccines. On November 17, 2005, the Committee will discuss developing new Pneumococcal Vaccines for U.S. licensure for adults.

Oral Presentations:

Between approximately 1:45 and 2:15 p.m., on November 16, 2005; and 1:00 and 1:30 p.m. on November 17, 2005, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before November 9, 2005.

Closed Committee Deliberations:

On November 17, 2005, from 8:30 to 9:55 a.m. the meeting will be closed to the public. 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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