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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, March 2, 2009 - Anascorp

 

Submission Type: Original Application   Submission ID:  125335/0   Office: OBRR  

 
Product:
Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine)
 
Applicant:                                                                       
Instituto Bioclon, S.A. de C.V.          
 
Telecon Date/Time:  04-MAR-2009 12:00 AM              Initiated by FDA?  Yes
Telephone Number:    
 
Communication Categorie(s):
Information Request
 
Author:  DEBRA CORDARO
 
Telecon Summary:
Excel spreadsheets requested
 
FDA Participants:   Debbie Cordaro
 
Non-FDA Participants:    ------------(b)(4)-------
 
Trans-BLA Group: No
 
    
Related STNs:  None
Related PMCs:  None
Telecon Body:
On Feb 6, 2009, the firm was sent an IR asking for an Excel spreadsheet of the PK data. Amendment 5 included a hardcopy of the spreadsheet but not the Excel spreadsheet itself. The firm was asked to send in the spreadsheet.
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