
Record of Telephone Conversation, April 3, 2012 - Flublok

 
 
 

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

Product:

Influenza Vaccine

Applicant:

Protein Sciences Corporation

Telecon Date/Time: 03-Apr-2012 04:25 PM        Initiated by FDA? Yes

Telephone Number: Communication conveyed via e-mail

Communication Categorie(s):

1. Advice

Author: TIMOTHY FRITZ

Telecon Summary:

Remaining advice for PSC Feb 15, 2012 questions.

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:                      Tuesday, April 03, 2012 4:25 PM

To:                         'Penny Post'

Subject:                 CBER Response to PSC February 15, 2012, Questions 3 and 4.

 

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 regarding –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 question #3 related to the –b(4)-------- study and general question #4. Comments regarding the –b(4)-------- studies have already been provided (CBER communication provided via e-mail on March 2, 2012).

 

PSC Question:

3. Does the Agency agree that the –b(4)-------- assay improvements described here will provide an acceptable level of detection of –b(4)-- to assess its presence or absence in FluBlok?

 

CBER RESPONSE:

You have agreed to improve the sensitivity of the –b(4)-------- assay by using a –b(4)----------- approach to evaluate –b(4)------------------------------------------------------------------------------ FluBlok Drug Product equivalent to 3 doses (representing 3 x 135 µg formulated rHA).

 

We have the following comment with regard to enhancing detection of –b(4)------------------------ in FluBlok. We agree that using –b(4)--------------------------------------------------------- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

Additional comments:

 

--b(4)----  

 

--b(4)---  

 

PSC Question:

4. Does the Agency agree that the studies proposed in this document adequately assess the potential risk associated with the presence of –b(4)------ in FluBlok? If not, could the Agency please specify in detail what would be required to address this concern?

 

CBER RESPONSE: 

 

On March 2, 2012 (e-mail from Timothy Fritz of CBER to Penny Post of PSC) in response to question 1, we provided advice on the methodology of the –b(4)---- studies ---b(4)---   --b(4)--- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 

 

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

 

--b(4)---  . 

 

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. 
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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