Record of Telephone Conversation - December 8, 2009 - Prevnar 13

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  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:
Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  08-DEC-2009 12:00 AM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  JULIENNE VAILLANCOURT

Telecon Summary:
Format for Submitting CMC PMCs

FDA Participants:                     Julie Vaillancourt

Non-FDA Participants:             Jack Love

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

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.