
Record of Telephone Conversation,June 20, 2014 -- TRUMENBA


 

 

Submission Type: BLA Submission ID: 125549/0 Office: OVRR

Product:
Meningococcal Group B Vaccine

Applicant:
Wyeth Pharmaceuticals Inc.

Telecon Date/Time: 20-Jun-2014 02:30 PM Initiated by FDA? Yes

Telephone Number: 877-580-3949

Communication Categorie(s):
1. Advice
2. Other - iPSP discussion

Author: KAREN FARIZO

Telecon Summary: 
iPSP discussion

FDA Participants: Karen Farizo and Theresa Finn

Non-FDA Participants: Donna Boyce and Carmel Devlin

Trans-BLA Group: No

Related STNs: None
Related PMCs: None
Telecon Body:

Pfizer requested the call to obtain clarification on the 30 May 2014 telecon with CBER regarding submission of the initial Pediatric Study Plan (iPSP). In the BLA, Pfizer submitted a request for a partial waiver (ages 0 to 12 months) and a request for deferral of pediatric studies (ages 12 months to 10 years). However, Pfizer did not submit the full content of the iPSP. CBER reiterated that Pfizer should submit the full iPSP to the BLA. Pfizer indicated that they will submit the iPSP to the BLA by 27 June 2014 (consistent with advice from 30 May 2014 telecon that the iPSP should be submitted in the last rolling piece of the BLA or within 30 days of the last piece being submitted). CBER also informed Pfizer that for the deferred studies, they should include the following dates:
•Estimated final protocol submission date
•Estimated study initiation date
•Estimated study completion date
•Estimated final report submission date
•Target date of supplemental application submission

CBER reiterated that at this time, Pfizer does not need to submit the iPSP to their IND 13812.
