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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon with Fresenius Kabi - 11/30/2007

Telecon with Fresenius Kabi

30-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 told him of the new Pediatric Research Equity Act (PREA) requirement that pediatric studies must be done in children. Dr. Landow explained that there were 3 categories in children: new born to 2 years, 2 years to 12 years and 12 years to 16 years.

     

     

  • Mr. Coln stated that Fresenius Kabi had provided a pediatric statement in Module 2 Vol 4, 3rd tab.

     

     

  • Dr. Landow noted that Fresenius Kabi had only done study in new born to 2 year old and needed to provide justification as to why a waiver should be granted for those age groups.

     

     

  • Mr. Coln told us that we would bring the issue to F. Kabi and would get back to us ASAP.

     

Franklin T. Stephenson
Regulatory Project Manager
OBRR/DBA