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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Television Conversation, April 17, 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:  17-APR-2009 11:45 AM               Initiated by FDA?  Yes
Telephone Number:    
 
Communication Categorie(s):
Advice
 
Author:  DEBRA CORDARO
 
Telecon Summary:
Response to requests from firm
 
FDA Participants:   Debbie Cordaro
 
Non-FDA Participants:    ------(b)(4)------
 
Trans-BLA Group: No
 
    
Related STNs:  None
Related PMCs:  None
Telecon Body:

-------(b)(4)-- had asked if the response time to the information request sent April 14, 2009 could be extended to after the facility inspection. FDA agreed to the extension.
At the firm’s request DMPQ clarified that horse facility part of Bioclon does not need a registration number.