Available for Public Disclosure without Redaction Magnevist Injection & Pharmacy Bulk Package

BRIEFING DOCUMENT Pneumococcal Adult Vaccine OPEN SESSION VRBPAC Meeting November 17 2005 AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION

Available for Public Disclosure without Redaction

A number of surveillance studies have been conducted looking for organisms with decreased susceptibility to antimicrobial agents in natural environments. There was no evidence of shifts in populations or development of resistance to the antimicrobial agents in any of these studies. Nor was there any evidence of a correlation of resistance between antimicrobial-tolerant strains and antibiotic re...

Available for Public Disclosure without Redaction

Control of microorganisms found on the skin of individuals is important to public health. The potential for the transmission of opportunistic pathogens to oneself or to others is significant, in the home, in institutional and commercial settings, as well as in healthcare settings. The risk of infection or acquisition of disease from the transmission of microorganisms can be correlated to specif...

Background Document on the UGT1A1 Polymorphisms and Irinotecan Toxicity: ACPS November 3, 2004 Advisory Committee Meeting AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION October 4, 2004 AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION

s/Presentations Ando, Proc ASCO 2003 Unspecified Unspecified 119 Japanese genotyped for UGT1A1*28 and UGT1A1 T3263G Not evaluated Severe tox 6.2-fold more likely in pts with both UGT1A1*28 and T3263G than in pts with wild-type UGT1A1 Chowbay, Proc ASCO 2003 100 mg/m, weekly Prospective 20 Chinese pts genotyped; 12 6/6, 6 6/7, and 2 7/7 No significant genotypedependent differences in irino, SN-3...

Advisory Committee Briefing Materials: AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION TABLE OF CONTENTS

The development of echo contrast agents that can provide reliable opacification of the myocardium after intravenous injection is an important advancement for the clinical application of contrast echocardiography. In this study, the hemodynamic effects and echocardiographic characteristics of a new lipid-fluorocarbon echo contrast agent, Aerosomes MRX 115 (ImaRx Pharmaceutical Corp., Tucson, Ari...