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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon with Fresenius Kabi - 12/14/2007

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, Pauline Cottrell
Baxter Participants: Mr. Coln

Agenda

Conversation Record:

  • We contacted Mr. Coln and indicated to him that the PREA Advisory committee has conviened and the following suggestions have been placed forward:

     

    1. For Fresenius Kabi to commit to perform a Safety Study in 2- 12 year old population similar to a sepsis trial. FDA would need to see a description of the methods, population, overview, and an agreement to due diligence. Fresenius Kabi must follow the schedule as agreed.

       

       

    2. The language for the pediatric section needs to be strenghtened to indicate that the 2- 12 age range population has not been studied therefore, they cannot recommend a dose as of yet.

       

     

  • Mr. Coln told us that we would bring the issue to F. Kabi and would get back to us by Monday Dec. 17, 2007.

     

Franklin T. Stephenson, Pauline Cottrell
Regulatory Project Manager
OBRR/DBA