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Vaccines, Blood & Biologics

Record of Telephone Conversation, November 9, 2012 - Flublok


Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Influenza Vaccine
Protein Sciences Corporation
Telecon Date/Time: 09-Nov-2012 11:06 AM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Information Request
2. Advice
Telecon Summary:
--b(4)------------------ and pharmacovigilance comments.
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, November 09, 2012 11:06 AM
To:                         'Penny Post'
Subject:                 CBER Information Request for STN 125285 (Flublok)
Importance:           High
Attachments:         CBER information request STN 125285.pdf
Dear Dr. Post-
We have reviewed your July 16 and October 15, 2012, submissions (Amendments 57 and 66, respectively) to STN 125285. We have the following comments and requests for additional information:
Amendment 57
Regarding your response to CBER’s March 2, 2012, Information Request:
1.     –b(4)---------------------------------------------- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2.     The details of the Limit of Detection (LOD) assay (Appendix 2, page 3) are confusing: --b(4)---- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regarding your response to CBER’s April 3, 2012, Information Request:
3.     Please provide the data for the –b(4)-- analysis of the –b(4)------------------- Flublok samples shown in Table 3 (page 15 of 25), for the positive and negative controls included in the –b(4)------- analysis (indicated in Table 1, appendix 3), and also the data for the assay standards to relate –b(4)------------------------.
4.     Regarding the b(4) values shown in Table 3 that suggest –b(4)--------------------- in Flublok, we have the following comments: 
a.      We acknowledge that you have conducted multiple studies to investigate the    -b(4)---. Please indicate whether you have observed –b(4)------------------------------------------- of the drug product or monovalent bulk and submit –b(4)---- used for the evaluation.  
b.     Please comment on plans to monitor the –b(4)-------- in the monovalent bulk lots or final product.  It may be prudent to record the –b(4)---------- using a validated, quantitative –b(4)--- assay for future reference.
5.     Results from –b(4)------------------- assay and –b(4)-------------------------- assay (-b(4)----------------------) are shown in Figures 3 and 4, respectively. The results show that     –b(4)---- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Amendment 66
Regarding your response to Comment 7 of our September 28, 2012, Information Request pertaining to your proposed Phase 4 study:
6.     As proposed in your May 8, 2008, submission to STN 125285 (Section, we recommend that you conduct the Phase 4 observational safety study in persons 18 years of age and older under a clinical protocol and recommend that this study be conducted as a Postmarketing Commitment (PMC).  We recommend that you submit a study protocol and statistical analysis plan to CBER for review prior to initiating the study.
Please provide your response as an Amendment to STN 125285.  In your reply, we recommend that you restate our request and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference.
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.
WOC2 HFM-478
1451 Rockville Pike
Rockville, MD 20852
Phone: 301-796-2640
Fax: 301-827-1597
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