


Record of Telephone Conversation, March 7, 2012 - Hyqvia




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(System Info - 193039 SHIELDS MARK 03/07/2012 08:33:38 SHIELDSM)

RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA Submission ID: 125402/0
Office: OBRR
Product: Immune Globulin Infusion (Human), 10% with Recombinant Human 
Hyaluronidase
Applicant: Baxter Healthcare Corporation
Telecon Date/Time: 02-Mar-2012 12:39 PM        
Initiated by FDA? Yes
Telephone Number: 
Communication Categorie(s):
1. Information Request

Author: LAURENCE LANDOW

Telecon Summary:
I telephoned the sponsor to ask for clarification about duration time of 
infusion described in the clinical section of the PI for IGIV vs. IGSC without 
rHuPR20.

I was told I would receive a response on the next business day.

FDA Participants: None

Non-FDA Participants: None

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

I telephoned the sponsor to ask for clarification about duration time of 
infusion described in the clinical section of the PI for IGIV vs. IGSC without 
rHuPR20.

I was told I would receive a response on the next business day.
 

    
 
