
Tcon with RDT re: STN 125335/0 Email, July 19, 2011 - Anascorp

 
 

From:                     Fisher, Robert

Sent:                      Tuesday, July 19, 2011 12:23 PM

To:                         Shields, Mark

Cc:                         Cordaro, Debbie

Subject:                 Tcon with RDT 1200 19 July 2011 re: STN 125335/0

 

Hi Mark. I just had a quick tcon with Jennifer at RDT to discuss the submission that came in yesterday.   I explained to her that the new cresol and sulfate specifications (expressed as mg/vial) should not exceed the old specifications (expressed as a percentage) when the vial fill volume is taken into account. I also indicated that we may need an additional revision on the lot release template due to a potential typo in the specifications. 

 

Could you post this to the file for 125335/0? Thanks…

 

 

 

Robert W. Fisher, Ph.D.

Staff Fellow, Laboratory of Plasma Derivatives

FDA/CBER/OBRR/DH

202-329-3957

Robert.Fisher@fda.hhs.gov