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Vaccines

Record of Telephone Conversation, March 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-Mar-2012 03:30 PM        Initiated by FDA? Yes
Telephone Number: norris.h.pyle@gsk.com
Communication Categorie(s):
1. Advice
 
Author: KIRK PRUTZMAN
Telecon Summary:
CBER's response to GSK's IR about LRP items 1, 21, and 22
FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN
Non-FDA Participants: NORRIS PYLE
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
From: Prutzman, Kirk C
Sent: Friday, March 23, 2012 3:31 PM
To: 'Norris Pyle'
Cc: Temenak, Joseph; Staten, David
Subject: RE: MenHibrix: LRP Teleconference
 
Norris,
I received the following response from our reviewers regarding your questions about Items 1, 21, and 22:
 
We will prefer to get information requested in item 1 the way it is requested and results in items 21 and 22 in the templates provided. We are making these changes for new approved products and will be moving to already licensed products in a phased manner to bring consistency in lot release protocols. If the GSK wants to change LRPs for other licensed vaccines now, they should work with Karen Campbell to ensure that required information is provided to CBER in required templates. Otherwise, we will go to already licensed products if any revisions to LRP is required as a consequence of a supplement or in a plan being worked out in our group.
 
Regards,
 
Kirk
 
 
From: Norris Pyle [mailto:norris.h.pyle@gsk.com]
Sent: Friday, March 23, 2012 7:13 AM
To: Prutzman, Kirk C
Subject: RE: MenHibrix: LRP Teleconference
 
Hi Kirk,
 
The team clarified that the question pertains to headers and templates – so here is the reworded question. So here is the reworded question just to be clear.
 
Thank you ‐ Norris
 
In Items 1, 21, and 22. GSK proposes to maintain the headers and templates for tests listed in items 21 and 22 as presented in the current LRP draft as this is consistent with the format used for all other US vaccines. Is this acceptable?
 
 
From: Prutzman, Kirk C [mailto:Kirk.Prutzman@fda.hhs.gov]
Sent: Thursday, March 22, 2012 10:57 AM
To: Norris Pyle
Subject: RE: MenHibrix: LRP Teleconference
 
Norris,
I sent your question to the reviewers. We are having FDA-wide email problems right now (I am one of the few who has email access) so I am not sure when they will be received. I will be in touch when we have comments. The CBER participants at today's tcon were:
 
KIRK PRUTZMAN
JOSEPH TEMENAK
RAJESH GUPTA
KAREN CAMPBELL
WILLIE VANN
TINA ROECKLEIN
ALFRED DEL-GROSSO
JOSEPH QUANDER
CATHERINE POOLE
JENNIFER BRIDGEWATER
FREYJA LYNN
 
Regards,
 
Kirk
 
From: Norris Pyle [mailto:norris.h.pyle@gsk.com]
Sent: Thursday, March 22, 2012 10:42 AM
To: Prutzman, Kirk C
Subject: MenHibrix: LRP Teleconference
 
Hi Kirk,
 
I’ll be writing up GSK’s draft minutes for the teleconference we had this morning – I’ll provide it to you then to help in your official minutes. Can you send me a list of the CBER attendees?
Also, I had one post‐meeting comment from GSK’s LRP people regarding the headers discussed in Items 1, 21, and 22. GSK proposes to maintain the headers as presented in the current LRP draft as this is consistent with the format of the headers for all other US vaccines. Is this acceptable?
 
Let me know – thank you ‐ Norris