
Record of Telephone Conversation, March 2, 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:  04-MAR-2009 12:00 AM              Initiated by FDA?  Yes

Telephone Number:    

 

Communication Categorie(s):

Information Request

 

Author:  DEBRA CORDARO

 

Telecon Summary:

Excel spreadsheets requested

 

FDA Participants:   Debbie Cordaro

 

Non-FDA Participants:    ------------(b)(4)-------

 

Trans-BLA Group: No

 

    

Related STNs:  None

Related PMCs:  None

Telecon Body:



On Feb 6, 2009, the firm was sent an IR asking for an Excel spreadsheet of the PK data. Amendment 5 included a hardcopy of the spreadsheet but not the Excel spreadsheet itself. The firm was asked to send in the spreadsheet