
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