Record of Telephone Conversation - November 25, 2009 - Prevnar 13

System Info - 120673  SMITH, MICHAEL J  21-Feb-2010 11:38:26  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:  25-NOV-2009 12:00 AM              Initiated by FDA?  Yes
Telephone Number:  845-602-1283   

 

Communication Categorie(s):
Information Request

 

Author:  JULIENNE VAILLANCOURT

 

Telecon Summary:
Clinical PMC's requested

 

FDA Participants:                    Julie Vaillancourt

 

Non-FDA Participants:            Jack Love

 

Trans-BLA Group: No

 

Related STNs:  None

 

Related PMCs:  None

 

Telecon Body:
The sponsor was requested to submit the agreed upon set of clinical post marketing commitments (PMCs), as would be expected to appear in an eventual approval letter.   CBER advised the sponsor to refer to CBER SOPP 8415 for guidance concerning exact elements to include for each written PMC, (e.g. date of final protocol submission, etc.).  Also, the sponsor was requested to provide synopses for the two recently proposed postmarketing studies to monitor otitis media effectiveness post licensure.  Specifically, these studies are 1) the national database study to monitor rates of OM-related ambulatory visits, and 2) the OM surveillance study to be conducted by ------(b)(6)------ in Texas utilizing data from a network of eight pediatric hospitals across the country.  The sponsor agreed to provide these items.