
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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