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Allergenic Products Advisory Committee

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February 10, 2000 Meeting

Date and Time

The meeting will be held on February 10, 2000, 8:30 am to 3:30 pm.

Location

Holiday Inn-Bethesda, Versailles Ballrooms I & II, 8120 Wisconsin Avenue, Bethesda, MD 20814, 301-652-2000.

Contact Person

William Freas, Ph.D., or Pearline Muckelvene, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12388. Please call the Information Line for up-to-date information on this meeting.

Agenda

The committee will receive an update on the organizational changes of the Laboratory of Immunobiochemistry (LIB), it's regulatory activities (including reference replacements and lot release statistics) and its research activities. The committee will hear presentations and discuss the following regulatory issues: potency limits for standardized allergen vaccines, selection of allergen extracts for standardization and a proposed algorithm for the standardization of new allergens.

Oral Presentations

Between approximately 11:00 am and 12:00 noon oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before February 3, 2000.

 

 
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