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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon PNR - August 12, 2009

RECORD OF TELEPHONE CONVERSATION

 

Submission Type: Original Application   Submission ID:  125329/0    Office: OBRR  

Product:

Immune Globulin Intravenous (Human), 5% Liquid

Applicant:                                                                        

Bio Product Laboratory          

Telecon Date/Time:  12-AUG-2009 12:00 AM              Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Advice

Author:  HON SUM KO

Telecon Summary:

Need for new proprietary name

FDA Participants:   Hon-Sum Ko

Non-FDA Participants:    Howard Smith

Trans-BLA Group: No  

Related STNs:  None

Related PMCs:  None

Telecon Body:

BPL was contacted and informed that a new proprietary name was needed. They were asked to submit a new name in one week.