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Vaccines

Record of Telephone Conversation, October 5, 2012 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product:
Influenza Vaccine
Applicant:
Protein Sciences Corporation
Telecon Date/Time: 05-Oct-2012 01:05 PM        Initiated by FDA? Yes
Telephone Number: Communicated via e-mail
Communication Categorie(s):
1. Information Request
Author: TIMOTHY FRITZ
Telecon Summary:
Confidence intervals for Amendment 63 data (clinical subanalyses)
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, October 05, 2012 1:05 PM
To:                         'Penny Post'
Subject:                 CBER Information Request STN 125285
 
Importance:           High
Dear Dr. Post-
 
We have received your September 28, 2012, response (STN 125285, Amendment 63) to CBER’s September 9, 2012 Information Request regarding gender, racial and ethnic sub-group analyses and have the following additional request:
 
1. Please revise Tables 1, 2, 3, 4, 5, 7, and 8 to include 95% confidence intervals for each point estimate.
 
Please submit your response as an amendment to STN 125285. If you have any questions, please contact the Regulatory Project Chair, 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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