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December 12, 2013: Allergenic Products Advisory Committee Meeting Draft Agenda

FOOD AND DRUG ADMINISTRATION
Center for Biologics Evaluation and Research
26th Meeting of the Allergenic Products Advisory Committee
FDA White Oak Campus, Bldg. 31 Great Room A
Silver Spring, Maryland
December 11-12, 2013

DRAFT AGENDA

Thursday, December 12, 2013

8:30 a.m.   Call to Order and Opening Remarks Michael Nelson, MD, PhD
Chair, APAC
  Conflict of Interest Statement Donald Jehn, MS
DFO, APAC
Topic 2: Safety and efficacy of Grastek, a Timothy Grass Pollen Allergen Extract, tablet for sublingual use, manufactured by Merck
8:45 a.m. Introduction, Background and Presentation of Questions

 

Jay Slater, MD
9:00 a.m. Merck Presentation  
  Introduction to MK-7243 Scott Greenfeder, PhD
Director, Global Regulatory Group
Merck Research Laboratories
  MK-7243 Clinical Development Overview Methods of Efficacy Results Hendrik Nolte, MD, PhD
Section Head of Respiratory
Clinical Research
Merck Research Laboratories
  MK-7243 Overview of Safety
(Clinical and Post Marketing)
Jennifer Maloney, MD
Director, Clinical Research
Merck Research Laboratories
  MK-7243 Benefit/Risk Assessment Hendrik Nolte, MD, PhD
Section Head of Respiratory
Clinical Research
Merck Research Laboratories
10:00 a.m. Questions  
10:15 a.m. Break  
10:30 a.m. FDA Presentation Ronald Rabin, MD
Chief, Laboratory of Immunobiochemistry
11:15 a.m. Questions  
11:30 a.m. Open Public Hearing  
12:00 p.m. Lunch  
1:00 p.m. Committee Discussion and Vote  
3:00 p.m. Adjourn for the day