|
March 5, 2001 Meeting
Date and Time
The meeting will be held on March 5, 2001, 8:30 a.m. to 5:00 p.m.
Location
Holiday Inn-Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Avenue, Bethesda, MD 20814, 301-652-2000.
Contact Person
William Freas 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
On March 5, 2001, the committee will hear updates on: Laboratory of Immunobiochemistry personnel, lot release statistics, new guidance documents, research and standardization programs, and a compliance report. The committee will discuss whether master seed stocks of mold strains used for allergenic extracts should be rederived to reduce a theoretical risk of TSE transmission. The committee will also discuss the statistical power of clinical studies used to assess bioequivalence as it applies to allergen extract studies. In the afternoon the committee will discuss particulates that appear in allergen extracts and the effect of these particulates on the safety and efficacy on these products. In closed session the committee will receive a report on the status of an IND and PLA supplement.
Oral Presentations
Between approximately 11:10 and 11:40 am; and 2:40 and 3:10pm oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before February 21, 2001.
Closed Committee Deliberations
From approximately 3:30 to 5:00pm, the meeting will be closed to permit discussion and review of trade secret and/or confidential information. (5 U.S.C. 552b(c)(4)).
|
