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Anascorp PI revisions Email, July 20, 2011 - Anascorp

 

From:                     Fisher, Robert
Sent:                      Wednesday, July 20, 2011 11:33 AM
To:                         'Jennifer Spinella'
Cc:                         Shields, Mark
Subject:                 STN 125335/0 Anascorp PI revisions
 
Attachments:          Anascorp Revised Package Insert 072011 redline.docx
Hi Jennifer. I'm enclosing a tracked changes version of the PI you submitted yesterday; the clinical section is suggesting minor changes to the indication, and I found two specifications that needed to be corrected. 
 
(Anascorp Revised Package Insert document attached)
 
Robert W. Fisher, Ph.D.
Staff Fellow, Laboratory of Plasma Derivatives
FDA/CBER/OBRR/DH
202-329-3957
Robert.Fisher@fda.hhs.gov
 
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