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Advisory Committees

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
8:35Meeting 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

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

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