Officer/ Employee List for STN 125478/0, RAGWITEK

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service


Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

EMPLOYEE/OFFICER LIST MEMO

To: The File
 Date: April 15, 2014

BLA: STN 125478/0
 Sponsor: Merck Sharp & Dohme Corp.
 Product: RAGWITEK, Short Ragweed Pollen Allergen Extract, Tablet for Sublingual Use

From: CDR Elizabeth Valenti, MPH, REH/RS, RAC (U.S.)
 Signature:

Section 916 of the Food and Drug Administration Amendments Act (FDAAA) requires that the identity of each employee or officer who participated in the decision to approve an original application be listed and filed as part of the Action Package for that file.

The following employees and officers have consented to have their names published publicly as being a participant in the approval decision for this file.

Jennifer Bridgewater, M.P.H. Regulatory Coordinator
Dennis T. Cato, CSO Bioresearch Monitoring Reviewer
 Cherry Geronimo, B.S. CMC/Lot Release Reviewer
 Patricia Holobaugh, Ph.D. Chief, Bioresearch Monitoring Branch
 Amelia (Dale) Horne, Ph.D. Chief, Vaccine Evaluation Branch
 Cheryl Hulme, CSO CMC/Lot Release Reviewer
 CDR James Kenney, D.Sc. Supervisory Regulatory Management Officer, CMC
 Taruna Khurana, Ph.D. Product Reviewer
 David Martin, M.D. Deputy Director, Office of Biostatistics and Epidemiology
 Tammy Massie, Ph.D. Statistical Reviewer
 Ronald Rabin, M.D. Clinical Reviewer
 Daphne Stewart Carton and Container Labeling Reviewer
 Ching-Long (Joe) Sun, Ph.D. Toxicology Reviewer
 Deborah Trout, CSO CMC/Facility Reviewer
 Claire Wernly, Ph.D. CMC/Lot Release Reviewer
 Lihan Yan, Ph.D. Statistical Team Leader
