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U.S. Department of Health and Human Services

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January 28, 2014: Allergenic Products Advisory Committee Meeting Agenda

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
ALLERGENIC PRODUCTS ADVISORY COMMITTEE
MEETING # 27, JANUARY 28, 2014

FDA WHITE OAK CAMPUS CONFERENCE CENTER
BUILDING 31, CONFERENCE ROOMS B/C
SILVER SPRING, MD

Draft Agenda
8:30 a.m. Call to Order and Opening Remarks
Conflict of Interest Statement
Michael Nelson, M.D., Ph.D., Chair
Gail Dapolito, Designated Federal Officer
Open Committee Discussion:  Safety and Efficacy of Ragwitek, a Short Ragweed Pollen Allergen Extract, tablet for sublingual use, manufactured by Merck, indicated for immunotherapy for diagnosed ragweed pollen induced allergic rhinitis, with or without conjunctivitis
8:45 a.m. FDA Introduction, Background and Presentation of Questions Jay Slater, M.D., Director
Division of Bacterial, Parasitic and  Allergenic Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research, FDA
9:00 a.m. Sponsor Presentations
Introduction
Scott Greenfelder, Ph.D.
Director, Global Regulatory Affairs, Merck
Efficacy of MK-3641 Hendrik Nolte, M.D., Ph.D.
Section Head of Respiratory, Clinical Development, Merck
Safety of MK-3641 Jennifer Maloney, M.D.
Director, Respiratory, Clinical Development, Merck
  Benefit/Risk Assessment of MK-3641 Henrik Nolte, M.D., Ph.D.
10:00 a.m. Questions and Answers  
10:15 a.m. Break  
10:30 a.m. FDA Perspective Ragwitek ®, Standardized Allergen Extract, Short Ragweed (Ambrosia artemisiifolia) sublinqual tablet for oral use Ronald Rabin, M.D., Chief
Laboratory of Imunobiochemistry
Division of Bacterial, Parasitic
and Allergenic Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research, FDA
11:15 a.m. Questions and Answers  
11:30 a.m. Open Public Hearing  
12:30 p.m. Lunch  
1:30 p.m. Committee Discussion and Vote  
3:30 p.m. Adjourn