System Info - 104141 SMITH, MICHAEL J 02-Sep-2009 17:03:23 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: 07-AUG-2009 02:30 PM Initiated by FDA? Yes
Author: MARION GRUBER
Extension of review clock & rescheduled VRBPAC meeting
FDA Participants: Karen Midthun, Norman Baylor and Marion Gruber
Non-FDA Participants: Jack Love, Emilio Emini and Carmel Devlin
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
See attached one-page MS Word file.
Record of Teleconference
|Date/Time:||August 7, 2009, 2:30 PM|
|Sponsor:||Wyeth Pharmaceuticals Inc.|
|Subject:||Extension of review clock & rescheduled VRBPAC meeting|
Background: On August 6, 2009, the Office of Vaccines Research and Review informed the sponsor about the Agency’s decision to cancel the September 10, 2009, VRBPAC meeting to discuss Prevnar 13, because it considered this meeting to be premature, given outstanding CMC issues identified in the review of the Prevnar 13 BLA to date, in particular, information contained in the July 23rd submission. The sponsor requested a follow-up meeting with CBER to discuss how to proceed forward.
The following were discussed during the present teleconference with the sponsor:
- CBER informed Wyeth that the July 23rd submission would be deemed a major amendment. Thus, the review clock would be extended by 90 days. It was agreed that a Major Amendment letter concerning BLA 125324 would be issued by CBER beyond the required 14-day time window of receipt of an amendment to the BLA, i.e., a few days later.
- CBER will work with Wyeth over the next couple of months in an attempt to resolve outstanding CMC issues. In this regard, CBER agreed to have a face-to-face technical meeting with the sponsor to clarify the outstanding CMC issues and expectations for a path forward.
- CBER informed the sponsor that the VRBPAC meeting to discuss Prevnar 13 would be rescheduled to take place on November 18 or 19, 2009.
- In addition, CBER informed the sponsor that a tentative closed session to discuss outstanding CMC issues would be planned. CBER noted that if the outstanding CMC issues are resolved prior to the VRBPAC meeting, then the closed session will not take place.