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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Monitoring residual virus Email, August 16, 2012 - Flucelvax

 

From:                    Huang, Ellen (CBER)
Sent:                      Thursday, August 16, 2012 5:22 PM
To:                         'Gollwitzer, Matthew'
Cc:                         Amin, Pankaj (Pete); Nelle, Timothy; Fritz, Timothy; Baldwin, Brenda; Ye, Zhiping
Subject:                 STN 125408/0 - Monitoring residual virus
 
Matt,
 
We have reviewed the information you sent in STN 125408 Serial Number 20 regarding the          ----(b)(4)---- assay that will be used to monitor for residual influenza virus. The information you provided appears adequate. Please consider selecting strain specific assay when you introduce different pandemic strains at your facility.
 
Regards,
Ellen Huang
Consumer Safety Officer
FDA/CBER/OCBQ/DMPQ/MRBII
1401 Rockville Pike, HFM-676
Rockville, MD 20852
Phone: 301.827.7199
Fax: 301.827.3536
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