Labeling changes - PowerPoint PPT Presentation

The Changing Landscape of Anticoagulation

The Changing Landscape of Anticoagulation. William D. Cahoon, Jr., PharmD, BCPS Cardiology Clinical Pharmacist VCU Health System April 12, 2012. Objectives. Review dabigatran post-marketing safety data Evaluate cardiovascular data for novel oral anticoagulants

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580 views • 49 slides

Regulations Subgroup Plan

Regulations Subgroup Plan. June 14,2013. Regulations Subgroup Plan. For June, take each of the three agencies and study their regulatory requirements applicable to HIT. Roadmap—FDA Example. Exercise Overview Health IT Use Case Themes regarding HIT FDA Device Regulatory Framework

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290 views • 17 slides

Challenges in Causality Assessment in Spontaneous Reporting Systems

Challenges in Causality Assessment in Spontaneous Reporting Systems. Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP 3 rd ICIUM, Antalya, Turkey November 2011. Disclaimer. These are my personal views not shared by the U.S. FDA or the U.S. government I am not representing the FDA

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726 views • 15 slides

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