Record of Telephone Conversation, November 22, 2013 - ALPROLIX

Submission Type: BLA    Submission ID: 125444/0    Office: OBRR
Product:          Coagulation Factor IX (Recombinant), Fc Fusion Protein
Applicant:       Biogen Idec Inc.
Telecon Date/Time: 22-Nov-2013 9:19 am        Initiated by FDA? Yes

Communication Category:     1. Other - Facility Issues

Author: Ellen Huang

Telecon Summary:     Request lyo telecon and information

FDA Participants: 
Ellen Huang, OCBQ/DMPQ

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

Telecon Body:
On November 22, 2013, FDA called Biogen Idec to request a telecon to discuss the acceptance criteria for the product temperature mapping provided in amendment STN 125444/0/45. FDA also asked for the raw data for the product temperature mapping.

The call ended at 9:25 am.
