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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, October 8, 2009 - Flublok

 

Submission Type: Original Application   Submission ID:  125285/0   Office: OVRR  
 
Product:
Influenza Vaccine
 
Applicant:                                                                        
Protein Sciences Corporation          
 
Telecon Date/Time:  08-OCT-2009 10:11 AM             Initiated by FDA?  No
Telephone Number:    
 
Communication Categorie(s):
Other
 
Author:  TIMOTHY FRITZ
 
Telecon Summary:
Response to CBER's October 6, 2009 Information Request for clarification of details of September 24, 2009 face-to-face meeting.
 
FDA Participants:  
Timothy Fritz
 
Non-FDA Participants:   
Penny Post
 
Trans-BLA Group: No
    
Related STNs:  None
 
Related PMCs:  None
 
Telecon Body:
 
Hi Tim,
 
Below are the answers to your questions regarding the September 24 BLA meeting:
 
1)  The attendees from BARDA were:  Dr. Maurice Harmon and Dr. Frank Arnold
2)  Comment 1t:  We indicated that we would set an upper specification on –b(4)--------------------- taking into account assay variability and strain specific trends . –b(4)------------------- over the specification would be investigated.
3)  Comment 1w:   We do not recall stating that 3 lots would be used to complete container closure integrity testing for shipping.  We feel that one lot with 3 shippers tested would be adequate.
4)  Peter Cardinal's title is:  Director, Validation 
 
Feel free to contact me if you have any other questions.
 
Penny
 
Penny L. Post, PhD
Vice President, Regulatory and Quality
Protein Sciences Corporation
1000 Research Parkway
Meriden, CT  06450
Phone:  203-599-6064 X156
FAX:     203-599-6069