System Info - 120685 SMITH, MICHAEL J 21-Feb-2010 22:33:51 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: 08-DEC-2009 12:00 AM Initiated by FDA? Yes
Author: JULIENNE VAILLANCOURT
Format for Submitting CMC PMCs
FDA Participants: Julie Vaillancourt
Non-FDA Participants: Jack Love
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Record of Teleconference
Date/Time: December 8, 2009, 1:30 PM
File: BLA 125324
Product: Prevnar 13
Sponsor: Wyeth Pharmaceuticals Inc.
Subject: Format for Submitting CMC PMCs
Sponsor Participant: Jack Love
CBER Participant: Julienne Vaillancourt
In follow-up to the December 3, 2009, e-mail to the sponsor, CBER requested that the sponsor submit the written CMC post marketing commitments (PMCs) in a letter as an amendment to the BLA. CBER explained that the CMC PMCs would not be included in the pending approval letter, but rather the sponsor’s letter to the BLA with the stated CMC PMCs would be referenced in the approval letter. It was agreed that language such as “we agreed to continue discussions concerning assay validation...” could be included in the letter to the BLA with regard to CBER’s requests concerning assay validation. Also, the sponsor noted that they have already committed to operate within tighter specifications, even if the revised tighter specifications are not in the BLA. Plans for the following day to discuss the ---(b)(4)---- calculation (i.e., for -----------(b)(4)-----), which concerns one of the CMC PMCs, were acknowledged.