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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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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