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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, October 1, 2009 - Flublok

 

Product:
Influenza Vaccine
 
Applicant:                                                                       
Protein Sciences Corporation          
 
Telecon Date/Time:  01-OCT-2009 01:44 PM              Initiated by FDA?  Yes
Telephone Number:    
 
Communication Categorie(s):
1. Advice
2. Information Request
 
Author:  TIMOTHY FRITZ
 
Telecon Summary:
Information Request regarding process validation of Flublok. In response to OS review and review of Aug 25, 2009 response to July 30, 2009 CBER IR.
 
FDA Participants:  
Timothy Fritz
 
Non-FDA Participants:   
Penny Post
 
Trans-BLA Group: No
    
Related STNs:  None
 
Related PMCs:  None
 
Telecon Body:
Hi Penny-
 
Attached is CBER's information request.
 
Thanks,
Tim
 
Timothy A. Fritz, Ph.D.
Microbiologist
FDA/CBER/OVRR/DVRPA/RRB2
WOC1 HFM-478 Suite 371N
1401 Rockville Pike
Rockville, MD 20852
Phone: 301-827-3070
Fax: 301-827-1597
 
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