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

 

 

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

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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)