
6/2/2007 Mid-Cycle Review - Chemistry, Manufacturing, Controls - RECOTHROM

 

 
M E M O R A N D U M

Department of Health and Human Services
 Public Health Service
 Food and Drug Administration
 Center for Biologics Evaluation and Research

Date: June 12, 2007 

To: File 

From: Nancy Kirschbaum 

Subject: Mid-cycle review memo, STN 125248: Thrombin, Topical (Recombinant), ZymoGenetics, Inc. Original BLA, Chemistry, Manufacturing, and Controls 

CC: Roman Drews
 Tim Lee
 Mark Shields
 Nisha Jain
 Nancy Waites 

Drug Substance
 3.2.S.1.2; 3.2.S.1.3 Structure and General Properties-

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