
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

 