
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.