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2. Presentation Outline. USP <467> Residual Solvents (RS): UpdateUpdated Overview: USP <467> and ICH Q3CCDER Residual Solvents Draft Guidance of 8/6/08Office of Generic Drugs (OGD) Website Update 10/28/08Summary and Future PlansUSP Glycerin Monograph Revision: UpdateUSP Revision Announcement
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1. 1 USP “Hot Topics” - USP <467> Residual Solvents, USP Glycerin Monograph, and More! WDCG/AOAC-SCS Joint Conference December 4, 2008 FDA at Irvine, CA Larry A. Ouderkirk Director – Compendial Operations Staff FDA/CDER/OPS-IO Silver Spring, MD