
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