AGENDA
FOOD
AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
ALLERGENIC PRODUCTS ADVISORY COMMITTEE MEETING
March 15, 2002
Versailles I and II
Bethesda Holiday Inn
Bethesda, Maryland 20814
8:00 a.m. Administrative Remarks
8:10
Opening Remarks
Samuel Lehrer, Ph.D., Committee Chair
COMMITTEE
UPDATES (Open Session)
8:15
Overview of the Division of Bacterial, Parasitic & Allergenic
Products (DBPAP)
Richard Walker, Ph.D., Division Director
8:30
Overview of the
Laboratory of Immunobiochemistry:
Personnel, organizational, and lot release activities
Jay E. Slater, M.D., DBPAP, Laboratory Chief
8:45 Discussion
8:50
Research Updates
Jay E. Slater, M.D
Ronald Rabin, M.D., DBPAP, FDA
9:35 Discussion
9:50 Break
10:05
Particulates in Allergen Extracts and Compliance Overview
Jay E. Slater, M.D
Teddi Lopez, OCBQ, FDA
10:35
Discussion
10:50
Reduction of Possible Exposure to TSE Agents in Allergen Extracts
Jay E. Slater, M.D
11:05 Discussion
11:15 Open Public Hearing
11:45 Lunch
REGULATORY DISCUSSION TOPICS (Open Session)
12:45 p.m. Considerations for the Regulation of Recombinant
Allergens for the
Diagnosis and Treatment of Allergic Disease
Jay E. Slater, M.D
1:15 Discussion
1:30
Glycerol in Allergen Extracts
Jay E. Slater, M.D
1:45 Discussion
2:00 Open Public Hearing
CLOSED SESSION
2:30 Presentation and Discussion of Site Visit Report
3:30 p.m. Adjourn