FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS
EVALUATION AND RESEARCH
ALLERGENIC PRODUCTS ADVISORY
COMMITTEE
APRIL 7, 2005
Holiday Inn, Bethesda, MD
AGENDA
Open Committee Discussion:
Topic I: FDA Proposed Strategy for the
Reclassification of Class IIIA Allergenic Products
8:30
a.m. Welcome and Administrative Remarks
Melvin
Berger, M.D., Ph.D., Chair
8:40
Meeting Statement
Executive
Secretary
8:45 FDA Perspective
Introduction and Overview
Jay Slater, M.D., Division of Bacterial, Parasitic
and Allergenic Products, CBER, FDA
9:00 Cockroach
Allergen Standardization
Jay
Slater, M.D.
9:45 Q&A
10:00 Research Overview
Ronald Rabin, M.D., Division of Bacterial, Parasitic
and Allergenic Products, CBER, FDA
10:30 Q&A
10:45 Break
11:00 Reclassification of IIIA Allergenic
Products
Jay
Slater, M.D.
11:45 Q&A
12
noon Open Public Hearing
1:00
p.m. Lunch
2:00 Committee
Discussion
4:00 Topic II: FDA Critical Path Initiative Update
3:30 FDA’s “Critical Path” Initiative
Kathryn Carbone, M.D.,
Office of the Director, CBER, FDA
Clinical Trial Design and Other
Statistical Issues
Mary Foulkes, Ph.D., Office of Biostatistics and
Epidemiology,
CBER, FDA
4:20
p.m. Adjourn