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 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