• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

Vaccines

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
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.