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February 22, 1999 Meeting
Date and Time
The meeting will be held on February 22, 1999, 8:00 am to 5:00 pm.
Location
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Holiday Inn-Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Avenue, Bethesda, MD.
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.
Agenda
The committee will discuss the current organization and the research programs of the Laboratory of Immunobiochemistry in the Division of Allergenic Products and Parasitology, OVRR. The committee will also discuss regulatory proposals concerning the potency limits for standardized allergen vaccines, requirements for protein content of these vaccines, modifications of the competitive ELISA assay, proposed package insert for allergen extracts, issues regarding use of pure allergens versus U.S. Standards, and an update on the status of Class IIIA allergen extracts.
Oral Presentations
Between approximately 1:00 and 2:00 pm oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before February 16, 1999.
Closed Committee Deliberations
From 3:00 to 5:00 pm the meeting will be closed to permit discussion and review of trade secret and/or confidential information regarding applications under FDA review.
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