
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