A Global Crisis – The War on Suicide in Japan

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Dr. Rene Duignan, not a professional film-maker but an Irish economist, was driven by a personal regret to create a film that would shed light on the crisis of suicide in Japan. Rene’s award winning documentary Saving 10,000 — Winning …

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Regulatory Trends in Reviewing Risk/Benefit Assessments: U.S. FDA Perspective

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Today’s blog will discuss regulatory trends in reviewing benefit/harm assessments in medical interventions. The important question here is: how do we balance the two? When we use the term “benefits” we are referring to “the good” that actually happens to …

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Drug-induced Hypertension – Potential New FDA Guidance?

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Last month, we introduced Ambulatory Blood Pressure Monitoring and its use in clinical trials. Today, we will discuss drug-induced hypertension and why regulatory agencies, such as the FDA, have recently shown some concern.  Some classes of drugs are known to …

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Why Use Ambulatory Blood Pressure Monitoring (ABPM) in Clinical Research?

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Written by: Dr. Robert Kleiman, Chief Medical Officer & Vice President, Global Cardiology Hypertension, or high blood pressure (BP), is one of the leading risk factors influencing the global burden of cardiovascular disease, resulting in an increased incidence of cardiovascular mortality, …

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Improving Your Drug’s Value Proposition throughout the Product Lifecycle: How Optimized Clinical Outcomes Assessment (COA) Strategies Can Drive Commercialization Success

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Typically, pharmaceutical and biotech companies have focused their Clinical Outcome Assessment (COA) development efforts solely on the requirements necessary for regulatory approval.  While we recognize that is extremely important, today we are going to discuss how pharmaceutical companies may reap …

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