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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon with Fresenius Kabi - 11/28/2007

Telecon with Fresenius Kabi

28-Nov-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