
Record of Telephone Conversation, March 02, 2012 - Flublok

 
 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR

Product:

Influenza Vaccine

Applicant:

Protein Sciences Corporation

Telecon Date/Time: 02-Mar-2012 01:08 PM        Initiated by FDA? Yes

Telephone Number: Communication conveyed via e-mail.

Communication Categorie(s):

1. Advice

Author: TIMOTHY FRITZ

Telecon Summary:

Partial advice re PSC's Feb 16 –b(4)- investigation plan.

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, March 02, 2012 1:08 PM

To:                         'Penny Post'

Subject:                 CBER comments for PSC proposed b(4) investigation

 

Importance:           High

Dear Dr. Post-

 

On February 15, 2012, PSC submitted their "b(4) Investigational Plan" in response to CBER's advice dated January 17, 2012 expressing concerns -----b(4)----------------------------------------------- in FluBlok. In addition to the b(4) Investigational Plan, PSC included 3 questions regarding their plan and 1 general question.

 

Below are CBER’s comments regarding PSC’s 2 questions related to the –b(4)------------- study. Comments regarding PSC’s remaining 2 questions will be addressed in a separate communication.

 

PSC Question:

1. Does the Agency find the protocol design of the proposed –b(4)----------- studies suitable for assessing the possible –b(4)--------------------------------------------------------- found in SF+ cells? In particular, --b(4)----------------------------------------------------------------------------------------------------, the controls, and the test articles (including –b(4)----------------) to be used appropriate?

 

CBER RESPONSE: 

--b(4)--  

 

--b(4)--- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

--b(4)--- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

--b(4)--- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

PSC Question:

2. Does the Agency agree that negative results from the proposed –b(4)---------- studies will be sufficient to exclude the presence in our cell line of –b(4)--------------------------- that would be a potential risk to vaccine recipients? If not, what additional studies does CBER consider necessary?

 

CBER RESPONSE: 

A negative result from the proposed –b(4)--------- studies will be acceptable to demonstrate the –b(4)-----------------------------------------. However, additional studies will be needed to demonstrate the –b(4)--- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- during –b(4)------------ study (as indicated in Attachment 1, page 4 of 9, item 7.2.1.5). The analysis will –b(4)--- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

Please contact the Regulatory Project Manager, Dr. Timothy Fritz, at 301-796-2640 if you have additional questions.

 

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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