
Telecon with Fresenius Kabi - 11/28/2007 - Voluven


 

 
Telecon with Fresenius Kabi

14-Dec-2007
RE: BN070012

Meeting called by: Franklin. Stephenson/ RPM

Type of meeting: Telecon 919-881-9900

FDA Participants: Franklin Stephenson, Dr. Lawrence Landow

Baxter Participants: Mr. Coln,

Agenda

Conversation Record:
•We contacted Mr. Coln and indicated to him that we had found additional errors in the PI Fresenius Kabi submitted on 27-Nov-07.
•Dr. Landow enumerated the errors and requested additional minor comments to PI.
•Mr. Coln said that he would communicate the corrections and will submit a non annotated version and clean a version by next week.
•Dr. Landow inquired as to the proposed wording of the Post-Marketing Commitment that Fresenius was supposed to submit.
•Mr. Coln indicated that they will be submitting that information as well.

Franklin T. Stephenson
Regulatory Project Manager
OBRR/DBA
