
Bioresearch Monitoring Filing Memo, April 19, 2012 - Kcentra

 

 
Memorandum                          

epartment of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research



DATE:          April 19, 2012

 

FROM:         Anthony Hawkins, Bioresearch Monitoring, HFM-664

                    Division of Inspections and Surveillance

                   Office of Compliance and Biologics Quality

                    Telephone: 301-827-6338            Fax: 301-827-6748

 

THROUGH: Patricia Holobaugh, Chief, Bioresearch Monitoring Branch HFM-664

 

SUBJECT:    Bioresearch Monitoring Filing Memo

                    BLA/STN: 125421-0          

                  Sponsor:   CSL Behring GmbH  

 

TO:              Ze Peng, BLA Committee Chair             HFM-392                

                   Leland Pierce, Clinical Reviewer             HFM-392 

                   Beth Walton, RPM                                 HFM-380 

                    

Based upon my initial review of the clinical data contained within this electronic submission, the submission appears fileable.

 

 

 

 

_____________________

Anthony Hawkins

Consumer Safety Officer