Advisory Committees

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

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


Thursday, December 12, 2013

8:30 a.m.  Call to Order and Opening RemarksMichael Nelson, MD, PhD
Chair, APAC
 Conflict of Interest StatementDonald Jehn, MS
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-7243Scott Greenfeder, PhD
Director, Global Regulatory Group
Merck Research Laboratories
 MK-7243 Clinical Development Overview Methods of Efficacy ResultsHendrik 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 AssessmentHendrik 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 PresentationRonald 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 

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