
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.