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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Record of Telephone Conversation, October 6, 2009 - Flublok

 

Submission Type: Original Application   Submission ID:  125285/0   Office: OVRR  
 
Product:
Influenza Vaccine
 
Applicant:                                                                        
Protein Sciences Corporation          
 
Telecon Date/Time:  06-OCT-2009 02:15 PM              Initiated by FDA?  Yes
Telephone Number:  203-599-6064
 
Communication Categorie(s):
Information Request
 
Author:  TIMOTHY FRITZ
 
Telecon Summary:
Dr. Penny Post was called to clarify some details of the September 24, 2009 face-to-face meeting with CBER.
 
FDA Participants:  
Timothy Fritz
 
Non-FDA Participants:   
Penny Post
 
Trans-BLA Group: No
    
Related STNs:  None
 
Related PMCs:  None
 
Telecon Body:
Dr. Post was phoned to ask for clarification regarding details of the September 24, 2009 face-to-face meeting between Protein Science Corporation (PSC) and FDA.
 
Dr. Post was asked if she cold provide:
1.         The names of the BARDA attendees at the meeting
2.         The title of Dr. Peter Cardinal
3.         Clarification on item 1t that –b(4)----------------------- would be addressed on       a strain-specific basis, and
4.         Clarification on item 1w regarding whether PSC indicated that it would repeat the             container closure integrity validation using 3 lots.
 
Dr. Post indicated that she would email a response as soon as possible.
 
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