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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, December 5, 2012 - BAT

 

Submission Type: BLA    Submission ID: 125462/0    Office: OBRR
Product:
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) (Equine)
Applicant:
Cangene Corporation
Telecon Date/Time: 05-Dec-2012 09:46 AM        Initiated by FDA? No
Telephone Number:
Communication Categorie(s):
1. Information Request
 
Author: ROBERT FISHER
Telecon Summary:
Request for clarification on: 1) ownership of donor horse herd; 2) responsibility for immunization program; 3) quality agreements related to questions 1 and 2.
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
Requested clarification on the horse herd used as a plasma source for the production of HBAT (aka NP-018, eBAT, BAT). Asked Cangene to provide details on 1) the ownership of donor horse herd (Cangene or USG); 2) responsibility for immunization program (currently performed by Auburn University personnel); 3) quality agreements related to questions 1 and 2.