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Vaccines

Record of Telephone Conversation, January 10, 2013 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product:
Influenza Vaccine
Applicant:
Protein Sciences Corporation
Telecon Date/Time: 10-Jan-2013 03:25 PM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Information Request
Author: TIMOTHY FRITZ
Telecon Summary:
Pregnancy registry study dates
FDA Participants: Timothy Fritz
Non-FDA Participants: Penny Post
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
PSC’s response to CBER’s request is provided following the CBER e-mail.
 
From:                    Fritz, Timothy
Sent:                      Thursday, January 10, 2013 2:25 PM
To:                         'Penny Post'
Subject:                 CBER request for Flublok pregnancy registry completion and report submission dates
 
Importance:           High
Dear Dr. Post-
 
We have reviewed the information in your postmarketing requirement (PMR)/postmarketing commitment (PMC) letter submitted via e-mail on January 9, 2013 which was also submitted as an amendment to STN 125285. We have the following comment regarding the timeline proposed for the pregnancy registry PMC:
 
We recommend that you provide an estimated study completion date to facilitate FDA tracking of this study. Accordingly, please provide an estimated final report submission date which should occur no later than 12 months following completion of data collection and analyses.
 
You may provide these dates via e-mail in reply to this request. 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
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.
 
 
 
From: Penny Post [PPost@ProteinSciences.com]
Sent: Thursday, January 10, 2013 3:22 PM
To: Fritz, Timothy
Cc: Manon Cox
Subject: RE: CBER request for Flublok pregnancy registry completion and report submission dates

Importance: High

Attachments: emfalert.txt
Dear Tim,
 
Please see below our estimated completion dates for our Pregnancy Registry PMC.
 
Estimated Study Completion Date:  31Dec2019
Estimated Submission of Final Report:  31Dec2020
 
Feel free to contact me if you have any questions.
 
Penny
 
 
Penny L. Post, PhD
Vice President, Regulatory
Protein Sciences Corporation
1000 Research Parkway
Meriden, CT  06450
Phone:  203-599-6064 X156
FAX:     203-686-0268
 
 
 
From: Fritz, Timothy [mailto:Timothy.Fritz@fda.hhs.gov]
Sent: Thursday, January 10, 2013 2:25 PM
To: Penny Post
Subject: CBER request for Flublok pregnancy registry completion and report submission dates
Importance: High
 
Dear Dr. Post-
 
We have reviewed the information in your postmarketing requirement (PMR)/postmarketing commitment (PMC) letter submitted via e-mail on January 9, 2013 which was also submitted as an amendment to STN 125285.  We have the following comment regarding the timeline proposed for the pregnancy registry PMC:
 
We recommend that you provide an estimated study completion date to facilitate FDA tracking of this study.  Accordingly, please provide an estimated final report submission date which should occur no later than 12 months following completion of data collection and analyses.
 
You may provide these dates via e-mail in reply to this request.  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
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.