
Statistical Review and Evaluation for Sponsor’s Response- BLA - TachoSil, December 15, 2009

 

 

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Biostatistics and Epidemiology
Division of Biostatistics

Statistical Review and Evaluation for Sponsor’s Response- BLA


BLA/Supplement Number:
125351/0/4 

Product Name:
Thrombin, Fibrinogen, patch 

Indication(s):
-------------------------------(b)(4)-------------------------------- an adjunct to hemostasis in cardiovascular surgery 

Applicant:
Nycomed DANMARK APS/1825 

Date(s):
CBER Receipt Date: 15-Dec-2009 

Review Priority:
Standard 

Statistical Branch:
Therapeutics Evaluation Branch 

Primary Statistical Reviewer:
Chunrong Cheng, Ph.D./HFM-219 

Concurring Reviewer:
Jessica Kim, Ph.D., Team Leader
Therapeutic Evaluation Branch/HFM-219
Ghanshyam Gupta, Ph.D., Branch Chief
Therapeutic Evaluation Branch/HFM-219 

Medical Office/Division:
OBRR/DH/CRB 

Clinical Reviewer(s):
Kimberly Lindsey, MD./HFM-392 

Project Manager:
Jie He/HFM-380 

Background:
In this submission, the sponsor provided responses to CBER’s information request.
FDA comment #1

Five (5) Pages Determined to be Non-Releasable:  (b)(4)
