October 25, 2011: Allergenic Products Advisory Committee Meeting Draft Agenda

Draft Agenda
Open Session

8:30 a.m.	Welcome and Introduction of Committee Robert Hamilton, Ph.D., D. ABMLI, Chair
8:35	Meeting Statement Donald Jehn, MS, Designated Federal Official

Topic I: CBER’s Review of Medical Literature on the Effectiveness of Non-standardized Allergen Extracts in the Diagnosis and Treatment of Allergic Disease

8:45	Efficacy Review of Allergenic Extracts: Background (1972 – 1985) Jay Slater, M.D., Director Division of Bacterial, Parasitic, & Allergenic Products, CBER, FDA
9:05	Efficacy Review of Allergen Extracts (2002 – Present) Jay Slater, M.D., Director Division of Bacterial, Parasitic, & Allergenic Products, CBER, FDA
9:35	Safety of Allergen Extracts Used for Allergen Immunotherapy Ronald Rabin, M.D., Chief Laboratory of Immunobiochemistry, CBER, FDA
9:55	Allergen Extract Database; Format, Conclusions Ronald Rabin, M.D., Chief Laboratory of Immunobiochemistry, CBER, FDA
10:55	Break
11:10	Potential Next Steps Jay Slater, M.D., Director Division of Bacterial, Parasitic, & Allergenic Products, CBER, FDA
11:30	Open Public Hearing
12:30 p.m.	Committee Discussion
1:30	Adjourn Meeting