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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, January 9, 2013 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product:
Influenza Vaccine
Applicant:
Protein Sciences Corporation
Telecon Date/Time: 09-Jan-2013 05:18 PM        Initiated by FDA? Yes
Telephone Number: Communicated via e-mail
Communication Categorie(s):
1. Advice
Author: TIMOTHY FRITZ
Telecon Summary:
Removal of CBER requested PMC
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:                      Wednesday, January 09, 2013 5:18 PM
To:                         'Penny Post'
Subject:                 CBER recommendation for Flublok PMRs/PMCs
 
Importance:           High
Dear Dr. Post-
 
In our e-mail sent on December 13, 2012, we requested that Protein Sciences Corporation (PSC) commit to providing the results of a pediatric efficacy study that may be conducted in the European Union as a PMC for Flublok approval. Following additional internal discussion, we have decided to remove this PMC from the Flublok approval. Therefore, you may remove this PMC from your response to our request for an updated PMR/PMC commitment letter sent via e-mail on the morning of January 9, 2013.
 
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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