Food and Drug Administration

Allergenic Products Advisory Committee

April 7, 2005


Topic I: FDA Proposed Strategy for the Reclassification of Catagory IIIA Allergenic Products

FDA Introduction and Overview, Jay Slater, MD (HTM) (PPT)

German Cockroach Allergen Standardization - Progress Report, Jay Slater, MD (HTM) (PPT)

Research Update, Ronald Rabin, MD (HTM) (PPT)

Reclassification of IIIA Allergenic Products, Jay Slater, MD (HTM) (PPT)

FDA's "Critical Path" Initiative, Kathryn Carbone, MD (HTM) (PPT)

Topic II: FDA Critical Path Initiative Update

Clinical Trial Design and Other Statistical Issues, Mary Foulkes, PhD (HTM) (PPT)