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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, December 12, 2011 - MenHibrix

 

Submission Type: BLA    Submission ID: 125363/0    Office: OVRR
Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Applicant:
GlaxoSmithKline Biologicals
Telecon Date/Time: 12-Dec-2011 02:35 PM        Initiated by FDA? Yes
Telephone Number: jody.a.gould@gsk.com, norris.h.pyle@gsk.com, elisa.b.harkins@gsk.com
Communication Categorie(s):
1. Information Request
 
Author: KIRK PRUTZMAN
Telecon Summary:
Request for data for Serology response Figures 5 and 6 and Tables 6-8.
FDA Participants: KIRK PRUTZMAN, DAVID STATEN, JOSEPH TEMENAK
Non-FDA Participants: JODY GOULD, NORRIS PYLE, ELISA HARKINS
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
Dear Jody,
 
We have been reviewing your responses to our Complete Response Letter dated September 21, 2011, and have the following information request.
 
1.  Regarding your responses to our serology questions (CR Letter Items 1, 2, and 3), please submit the data used to generate Figures 5 and 6 and the data used to calculate tables 6, 7, and 8 as data files. 
 
Regards,
Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
CBER/OVRR/DVRPA/CMC3
1451 Rockville Pike (WOC2)
Room 2241
HFM-481
Rockville, MD  20857
Phone:  (301) 796-2640