Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

Record of Telephone Conversation, January 9, 2013 - Flublok


Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Influenza Vaccine
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
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.
WOC2 HFM-478
1451 Rockville Pike
Rockville, MD 20852
Phone: 301-796-2640
Fax: 301-827-1597
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please notify the sender immediately by e-mail or phone.

Page Last Updated: 09/25/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.