Vaccines, Blood & Biologics
Telecon with Fresenius Kabi - 11/28/2007
Telecon with Fresenius Kabi
|Meeting called by:||Franklin. Stephenson/ RPM|
|Type of meeting:||Telecon
|FDA Participants:||Franklin Stephenson, Dr. Lawrence Landow|
|Baxter Participants:||Mr. Coln|
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