
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.