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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon with Fresenius Kabi - 11/29/2007

Telecon with Fresenius Kabi

29-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, Dr. Jungheinrich

Agenda

Conversation Record:

  • We contacted Dr. Jungheinrich and indicated to him that CBER preferred a change in the terminology of the PMC wording. Specifically, the term "will be provided". FDA would prefer language to the effect that the DMC will have access to unblinded data at anytime rather than data will be provided.

     

     

  • Dr. Jungheinrich agreed with our request. He indicated that regarding ------------------------------------------------------------------------------------------------------------

     

     

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  • FDA requested that Fresenius Kabi submit the final wording of the PMC and agree to it in writing. FDA explained that we would like then to submit the protocol within 3 months of the approval letter and the final clinical report within 18 months of the approval letter.

     

     

  • Fresenius Kabi indicated that the timing was unfeasible, they could not commit on something that they knew they could not do, they requested at least 36 months for submission of the final study report.

     

     

  • Dr. Landow told the sponsor that we would discuss this concern and get back to them.

     

Franklin T. Stephenson
Regulatory Project Manager
OBRR/DBA