System Info - 113387 SMITH, MICHAEL J 10-Dec-2009 10:29:10 SMITHM
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125324/0 Office: OVRR
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 01-MAY-2009 02:30 PM Initiated by FDA? Yes
Author: MICHAEL SMITH
RE: Email IR for 5 SOPs
FDA Participants: Mike Smith and Julie Vaillancourt
Non-FDA Participants: Jack Love and Carmel Devlin
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Smith, Michael (CBER)
Sent: Friday, May 01, 2009 2:31 PM
To: 'LOVEJ@wyeth.com'; 'DEVLINC@wyeth.com'
Cc: Vaillancourt, Julienne
Subject: RE: Request for additional documents for BLA 125324
Jack and Carmel,
I have an additional list of documents to request, please submit these documents to the BLA as an amendment.
1. Detailed SOPs for all serotype Pneumococcal Activation Processes.
2. Detailed SOPs for ------(b)(4)---- and Reconstitution for all serotypes.
3. Detailed SOPs for Conjugation Reaction for all serotypes.
4. Detailed SOPs for -----------(b)(4)------ impurity removal for all serotypes.
5. Detailed SOPs for ------------(b)(4)------ impurity removal for all serotypes.
End of email.