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Vaccines

Record of Telephone Conversation, April 28, 2012 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product:
Influenza Vaccine
Applicant:
Protein Sciences Corporation
Telecon Date/Time: 28-Apr-2011 01:25 PM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Advice
 
Author: TIMOTHY FRITZ
Telecon Summary:
PSC will track ring sizes for the BEVS-based 2009 H1 rHA reference antigen
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
From: Penny Post [mailto:Penny.Post@ProteinSciences.com]
Sent: Thursday, April 28, 2011 1:25 PM
To: Fritz, Timothy
Cc: Manon Cox
Subject: ring sizes
Hi Tim,
 
I double-checked our SRID SOP QT0077 and I was mistaken.  There is no criteria for ring sizes in this SOP.  We used to have this criteria in our original SRID SOP (QT0042).  It was removed and replaced with a requirement for relative potency between the reference antigen and test sample to align with CBER’s SRID SOP.
 
We will track ring sizes for the BEVS-based 2009 H1 rHA reference antigen, as per your request.
 
I apologize for the confusion.
 
Penny
 
Penny L. Post, PhD
Vice President, Regulatory and Quality
Protein Sciences Corporation
1000 Research Parkway
Meriden, CT  06450
Phone:  203-599-6064 X156
FAX:     203-599-6069