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Record of Telephone Conversation, March 5, 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:  05-MAR-2009 12:00 AM              Initiated by FDA?  Yes
Telephone Number:    
 
Communication Categorie(s):
Information Request
 
Author:  DEBRA CORDARO
 
Telecon Summary:
    
FDA Participants:   Debbie Cordaro
 
Non-FDA Participants:    --(b)(4)--
 
Trans-BLA Group: No
    
Related STNs:  None
Related PMCs:  None
Telecon Body:

The firm was called on March 5, 2009 seeking clarification of a statement submitted in the January 21, 2009 BLA. Following the pre-BLA meeting to discuss clinical issues, Bioclon provided minutes stating that when the BLA is submitted they intend to respond to disagreements with FDA’s comments for points 1, 3, 5 and 8 from that meeting.
 
The firm was asked were in the BLA these clarifications can be found.