
Record of Telephone Conversation, April 6, 2012 - Flublok

 
 
 

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

Product:

Influenza Vaccine

Applicant:

Protein Sciences Corporation

Telecon Date/Time: 06-Apr-2012 08:12 AM        Initiated by FDA? Yes

Telephone Number: Communication conveyed via e-mail

Communication Categorie(s):

1. Advice

Author: TIMOTHY FRITZ

Telecon Summary:

Clarification of CBER April 3, 2012, telecon.

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, April 06, 2012 8:12 AM

To:                         'Penny Post'

Subject:                 Clarification of April 3, 2012, CBER telecon

 

Importance:           High

Dear Dr. Post-

 

On April 3, 2012, CBER provided responses to questions submitted by Protein Sciences on February 15, 2012 (STN 125285, Amendment 51). In our response to Question 3, we discussed the use of "---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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