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(System Info - 191819 THOMPSON EDWARD 02/24/2012 14:11:42 THOMPSONED)

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: 24-Feb-2012 11:15 AM Initiated by FDA? No

Telephone Number: 877-658-5104

Communication Categorie(s):
 1. Advice

 Author: MARK SHIELDS

Telecon Summary:
 The tissue cross reactivity study is completed and will be submitted.

FDA Participants: Dorothy Scott, Jennifer Reed, Edward Thompson, Mark Shields

Non-FDA Participants: Angela Blackshere, Doug Hunt

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:
 Baxter called to inform FDA that the tissue cross reactivity "Phase II" study 
has been completed. Baxter indicated that an executive summary is available now, 
and the interim (draft) report will be sent to CBER within two weeks. Baxter 
indicated that there were no unexpected findings in the Phase II tissue cross 
reactivity study. Baxter stated that a data integrity assessment has been 
performed for this study, which was completed by contract at -(b)(4)--. FDA 
inquired whether staining of female reproductive tissue was observed with 
rHuPH20 directed antibodies. Baxter claimed there was no staining observed in 
female reproductive tissue.

END
 

    
 


