Record of Telephone Conversation - TachoSil, September 2, 2009

 
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  

Product:
 Fibrin Sealant

Applicant:                                                                        
 Nycomed Danmark ApS          

Telecon Date/Time:  02-SEP-2009 12:00 AM                Initiated by FDA?  Yes

Communication Categorie(s):
 Information Request

Author:  JIE HE

Telecon Summary:
 Clarify issue related to PREA

FDA Participants:  
 Kimberly Lindsey, Jie He

Non-FDA Participants:   
•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 STNs:  
 ------------(b)(4)-------------       

Related PMCs:  None

Telecon Body:
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?

Nycomed: Correct.

FDA: Thank you for the clarification.

 

 

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