System Info - 104129 HE, JIE 02-Sep-2009 16:22:45 HEJ
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125351/0 Office: OBRR
Nycomed Danmark ApS
Telecon Date/Time: 02-SEP-2009 12:00 AM Initiated by FDA? Yes
Author: JIE HE
Clarify issue related to PREA
Kimberly Lindsey, Jie He
- Camilla Wamberg, Regulatory Affairs Manager
- Bettina Twile, Director, Regulatory
- Kreesten Meldgaard Madsen, Medical Director
- Vilhelm Tetens, Senior Int. Medical Advisor
- Henrik Steen Andersen, Statistician
- Susanne Munk, Senior Project Director
- Kevin Johnson, US Agent for Nycomed
Trans-BLA Group: No
Related PMCs: None
FDA: There is no specific statement found in the submission that specifically addresses PREA. During pre-BLA discussions, Nycomed agreed to address PREA in some fashion, but the BLA submission does not formally address studies intended to fulfill PREA requirements. The proposed labeling for TachoSil suggests that the study TC-019 (a pediatric study in liver surgery) is intended to support use of TachoSil in the pediatric population.
Nycomed: Although not specifically addressed PREA in the submission, the particular reference we used in the label is the TC-019 study (liver resection in children).
FDA: For clarification, the study Nycomed intends to use to address US PREA requirements is TC-019?
FDA: Thank you for the clarification.