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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, February 23, 2012 - 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: 23-Feb-2012 04:40 PM        Initiated by FDA? Yes
Telephone Number: jody.a.gould@gsk.com; norris.h.pyle@gsk.com
Communication Categorie(s):
1. Information Request
 
Author: KIRK PRUTZMAN
Telecon Summary:
Information request for Items 23 and 24a in CR Letter #2
FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN
Non-FDA Participants: JODY GOULD, NORRIS PYLE
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
Dear Jody,
We have the following Information Request regarding your responses to Item 23 and Item 24a for STN 125363/21 (MenHibrix). 
 
Amendment 21 - Item 23    
DBSQC Information Request: In the response to CR Item 23 in m1.11.1 Quality Information Amendment 21, the summary results and cited numbers for the validation reports for MenC-TT and MenY-TT appear to be transposed in that the Validation Report numbers and Ranges tested correspond to MenY-TT and MenC-TT respectively. If our interpretation is correct, please resubmit this table.   
 
Amendment 21 – Item 24a. 
DBSQC information request: The response to Item 24a and Validation Report 9000015175RVM001/01 Version 3.0 Section 8.11 does not clearly address the basis for the calculation of recovery of -----(b)(4)----- --- (termed “-----(b)(4)------” in the report) and it is unclear where the cited (b)(4) recovery is reported. Please provide a clear calculation example as to how the stated recovery value has been obtained.
 
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