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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, June 9, 2009 - Flublok

 

Submission Type: Original Application   Submission ID:  125285/0   Office: OVRR  
 
Product:
Influenza Vaccine
 
Applicant:                                                                        
Protein Sciences Corporation          
 
Telecon Date/Time:  09-JUN-2009 12:54 PM              Initiated by FDA?  Yes
Telephone Number:    
 
Communication Categorie(s):
Information Request
 
Author:  TIMOTHY FRITZ
 
Telecon Summary:
Request for SAS programs used to analyze studies PSC04 and PSC06 to be submitted as an amendment to STN 125285
 
FDA Participants:   Timothy Fritz
 
Non-FDA Participants:    Penny Post
 
Trans-BLA Group: No
 
    
Related STNs:  None
 
Related PMCs:  None
 
Telecon Body:
 
Hi Penny-
 
In response to your June 8, 2009 emails to Rakesh Pandey, please submit the SAS programs used for the analysis of studies PSC04 and PSC06 on a single CD as an amendment to STN 125285.
 
Please organize the CD to contain two folders. One should be labeled "SAS programs PSC04" and the second should be labeled "SAS programs PSC06". Please place the corresponding SAS programs in the appropriate folder.
 
If you have any questions, please contact me a 301-827-3070.
 
Thanks,
Tim Fritz
 
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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