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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, January 10, 2010 - 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:  08-JAN-2010 12:00 AM               Initiated by FDA?  Yes
Telephone Number:    
 
Communication Categorie(s):
Meeting Request
 
Author:  DEBRA CORDARO
 
Telecon Summary:
Suggestions to postpone meeting
 
FDA Participants:  
Debbie Cordaro
 
Non-FDA Participants:   
-----(b)(4)-------------.
 
Trans-BLA Group: No
 
Related STNs:  None
 
Related PMCs:  None
 
Telecon Body:
 

---(b)(4)---- was informed that an internal meeting was held to prepare the Agency’s responses to the firm’s questions. During that meeting, it was determined that significant additional information was needed from the firm before FDA could answer the posed questions; without this new information, it is unlikely that the meeting objectives can be met.
 
It was suggested to Bioclon that they postpone this meeting and submit the information that will be requested in our proposed answers. FDA was willing to reschedule the meeting approximately two weeks after the additional information is received. Bioclon agreed to postpone the meeting; no new meeting request will be needed.