Advisory Committees

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 RemarksMichael Nelson, MD, PhD
Chair, APAC
 Conflict of Interest StatementDonald 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-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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