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Vaccines, Blood & Biologics

Record of Telephone Conversation, April 6, 2012 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product:
Influenza Vaccine
Applicant:
Protein Sciences Corporation
Telecon Date/Time: 06-Apr-2012 08:12 AM        Initiated by FDA? Yes
Telephone Number: Communication conveyed via e-mail
Communication Categorie(s):
1. Advice
Author: TIMOTHY FRITZ
Telecon Summary:
Clarification of CBER April 3, 2012, telecon.
FDA Participants: Timothy Fritz
Non-FDA Participants: Penny Post
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
From:                    Fritz, Timothy
Sent:                      Friday, April 06, 2012 8:12 AM
To:                         'Penny Post'
Subject:                 Clarification of April 3, 2012, CBER telecon
 
Importance:           High
Dear Dr. Post-
 
On April 3, 2012, CBER provided responses to questions submitted by Protein Sciences on February 15, 2012 (STN 125285, Amendment 51). In our response to Question 3, we discussed the use of "---b(4)------------------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------.
 
If you have any questions, please contact the Regulatory Project Manager, Dr. Timothy Fritz, at 301-796-2640.
 
Thank you.
Timothy A. Fritz, Ph.D.
Microbiologist
FDA/CBER/OVRR/DVRPA/CMC2
WOC2 HFM-478
1451 Rockville Pike
Rockville, MD 20852
Phone: 301-796-2640
Fax: 301-827-1597
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