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.