Telecon with Fresenius Kabi
Meeting called by: Franklin. Stephenson/ RPM
Type of meeting: Telecon 919-881-9900
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