System Info - 100153 SMITH, MICHAEL J 21-Jul-2009 11:37:05 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: 21-JUL-2009 10:00 AM Initiated by FDA? Yes
Author: MICHAEL SMITH
Telecon w/ Jack Love and Carmel Devlin suggesting a face-to-face meeting to discuss CMC issues related to serotype 5.
FDA Participants: Michael Smith and Willie Vann
Non-FDA Participants: Jack Love and Carmel Devlin
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
We called Jack and Carmel and told them that we don't think the CMC issues related to serotype 5 have been adequately addressed-specifically the -------(b)(4)------- issues. We suggested a face-to-face technical meeting with them in WOC before July 31, so the chemists from Wyeth and CBER can get together and discuss these issues and potentially arrive at a path forward to resolve these issues. Jack said they would like that opportunity to meet with us and a meeting will be scheduled ASAP.