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