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
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 25-NOV-2009 12:00 AM Initiated by FDA? Yes
Telephone Number: 845-602-1283
Author: JULIENNE VAILLANCOURT
Clinical PMC's requested
FDA Participants: Julie Vaillancourt
Non-FDA Participants: Jack Love
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
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.