
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.