


Information Request Email, August 12, 2011 - Hyqvia




  
 
From:                    Lewis, Kelly R
 Sent:                      Friday, August 12, 2011 11:10 AM
 To:                         'Maruya, Aiko'
 Cc:                         Blackshere, Angela L
 Subject:                 125402/0  Baxter Immune Globulin Infusion (Human), 10% 
with Recombinant Human Hyaluronidase, Original BLA - Information Request 

Hi Aiko,

This email conveys our request for additional information regarding your 
submission for STN 125402/0 that was submitted to the agency on June 30, 2011, 
as an Original Biologics License Application for Immune Globulin Infusion  
(Human), 10% with Recombinant Human Hyaluronidase.  Please respond by August 26, 
2011.

1.   Please update the stability data, particularly for the conformance batches 
of rHuPH20.

Bioresearch Monitoring:

2.   Please provide the data management plan that includes the data collection 
and management, resolution, and control processes specific to the studies.  
Please describe the management plan if data was directly captured/entered in to 
eCRFs (electronic case report forms).  Please note that if the data management 
plan implemented during the studies is a common plan used for all the studies 
described in the BLA it is sufficient to submit one plan.

3.   Please describe the clinical site monitoring plan used during the 
study(ies) for monitoring the study conduct including the investigational 
product (IP) dispensing.  For the audits conducted in study 160603, please 
include the audit certificates. 

4.   Section 9.6.1 in the study report (study 160603) states that the IP was to 
be dispensed only at the institution specified on the Form FDA 1572.  However, 
section 6.2 in the study report describes that third parties provided the IP 
supplies to the subjects’ home for infusion and describes roles provided by home 
care nurses.  Please clarify the statements and describe the roles and 
responsibilities of the third parties in the study. If any sponsor obligations 
were transferred please include the transferred obligations with the dates of 
such transfer and retention of responsibilities.

Please reply to confirm receipt of this information request.

Thanks,
 Kelly

Kelly Lewis, MS, MBA
 Regulatory Project Manager
 Food and Drug Administration
 Center for Biologics Evaluation and Research
 Phone: 301.827.9427
 Fax: 301.827.2857
 email: kelly.lewis@fda.hhs.gov

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