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Vaccines, Blood & Biologics
Submission Type: Original Application Submission ID: 125335/0 Office: OBRR
Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine)
Instituto Bioclon, S.A. de C.V.
Telecon Date/Time: 17-APR-2009 11:45 AM Initiated by FDA? Yes
Author: DEBRA CORDARO
Response to requests from firm
FDA Participants: Debbie Cordaro
Non-FDA Participants: ------(b)(4)------
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
-------(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.