Record of Telephone Conversation, February 12, 2014 - ALPROLIX

RECORD OF TELEPHONE CONVERSATION
 Submission Type: BLA    Submission ID: 125444/0    Office: OCBQ 
 Product:          Coagulation Factor IX (Recombinant), Fc Fusion Protein
 Applicant:       Biogen Idec Inc.
 Telecon Date/Time: 12-Feb-2014 5:26 PM        Initiated by FDA? Yes
 Communication Category:     1. Other – DMPQ Information Request
 Telecon Summary:     Visual inspection
 Telephone: 919.993.1121
 FDA Participants: 
 Ellen Huang, Consumer Safety Officer, OCBQ/DMPQ/BII

Non-FDA Participants: 
Biogen Idec Attendees:
Suzanne Stella, Director, CMC Regulatory Affairs

Telecon Body:

FDA initiated this teleconference to request additional details about their qualification program for the 100% visual inspection of the drug product. Specifically, FDA asked for details about the test set used to qualify the operators. Biogen Idec stated that they would contact -(b)(4)- to obtain this information.
