Record of Telephone Conversation - Cervarix, November 5, 2008

System Info - 94734 SHONE, DEANNA 20-May-2009 17:11:15 SHONEDE

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application Submission ID: 125259/0 Office: OVRR

Product:
Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed

Applicant:
GlaxoSmithKline Biologicals

Telecon Date/Time: 05-NOV-2008 03:52 AM Initiated by FDA? Yes
Telephone Number:

Communication Categorie(s):
Advice

Author: HELEN GEMIGNANI

Telecon Summary:
CBER's comments to GSK's 29-Aug-2008 CMC proposals.

FDA Participants:

Non-FDA Participants:

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:
From: Gemignani, Helen S
Sent: Wednesday, November 05, 2008 3:52 PM
To: 'byron.a.bravo@gsk.com'
Cc: 'Matt.Whitman@gsk.com'; 'Cynthia.A.D'Ambrosio@gsk.com'
Subject: CMC Comments
Byron,
Please refer to your August 29, 2008, amendment to BLA 125259/0. We have the following advice and comments:
1) In regard to the -------(b)(4)-------- bottle for MPL --(b)(4)--:
a) Please submit extractable, leachable, and container closure integrity studies.
b) Please provide justification that container closures are not affected by shipment of the product from Montana to Belgium.
c) Please provide justification to demonstrate that the validated -----(b)(4)----- cycles for MPL are not affected by the -------------------(b)(4)--------------------- bottles.
d) Please submit comparability studies.
2) In regard to the ----(b)(4)----- syringe plunger stopper and tip cap, please submit extractable, leachable, and container closure integrity studies.
Let me know if you have any questions or need clarification.
Helen
Helen Sullivan Gemignani
Regulatory Project Manager
FDA/CBER/OVRR
Division of Vaccines and Related Products Applications/Viral Vaccine Branch
(301) 827-3070