(System Info - 122590 HE JIE 03/11/2010 08:47:59 HEJ)
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125351/0 Office: OBRR
Fibrin Sealant Patch
Nycomed Danmark ApS
Telecon Date/Time: 10-Mar-2010 02:10 PM Initiated by FDA? Yes
Telephone Number: 1-919-456-4746
1. Information Request
Author: JIE HE
To request a pediatric deferral plan to study use of TachoSil in pediatric patients undergoing cardiovascular surgery
Kimberly Lindsey, MD
Carrie Langlais, PhD.
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Nycomed is requested to provide a pediatric deferral plan to study use of TachoSil in pediatric patients undergoing cardiovascular surgery and an overall plan for obtaining a general adjunct to hemostasis indication in pediatrics. Nycomed should also include how they intend to extrapolate the information in the adult studies to the pediatric studies since the safety numbers for pediatrics will be small. Response is expected by COB March 15, 2010.
Nycomed is also informed about additional change in the response the Agency has just received for the PI.