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The top documents tagged [clinical benefit slide]
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James Pink Medical Device Risk Management. Requirements The medical device industry is highly regulated and based upon a device specific risk rating for
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Accelerated Approval Update 2005 Ramzi Dagher, MD DDOP/OODP/CDER/FDA
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Effectiveness of Simulation in Healthcare Joseph Barton, MD, MHMS September 18, 2014
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“Progenitor Cell Therapy in AMI After Meta-Analyses Results ? Pro“ “Progenitor Cell Therapy in AMI After Meta-Analyses Results ? Pro“ Andreas M. Zeiher,
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Salvage Antiretroviral Therapy Guiding Principles, Strategies and the Role of Resistance Testing
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PHYSIOLOGICAL AND LABORATORY MARKERS OF DRUG EFFECT Arthur J. Atkinson, Jr., M.D. Senior Advisor in Clinical Pharmacology Clinical Center, NIH
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1 November 2005 ODAC: DOXIL ®, AIDS-related KS ODAC Discussion on Accelerated Approval 8 November 2005 DOXIL ® (doxorubicin HCl liposome injection) Treatment
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Meeting Agenda Presentations on endpoints –Regulatory issues –Scientific issues Pros and cons of end points –Classical end points –Non-classical end points
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Regional Anaesthesia and Thromboprophylaxis Dr Kate Fogg Royal Brompton Hospital
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Regulatory Background and Past FDA Approvals in Colorectal Cancer Amna Ibrahim M.D DODP, FDA
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