Tag Archives: Regulatory

Risk-Based Monitoring: From the Road Less Traveled to Productivity Superhighway

Risk-Based Monitoring:  From the Road Less Traveled to Productivity Superhighway By:  Mukhtar Ahmed, global vice president, life sciences strategy, Oracle Health Sciences The latest news on the growing cost of conducting clinical trials is becoming a major concern for company sponsors and trial co-operative groups.  Clinical trials cost 60% more today than they did just […]
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NICE's Tarceva Decision "Perverse", Says Roche

The UK National Institute for Health and Care Excellence’s (NICE) decision that relapsed non-small cell lung cancer patients should no longer have access to Roche’s cancer pill Tarceva (erlotinib) is a setback for lung cancer care in England and Wales, where “over 1,000 patients a year will be left without an active treatment option after […]
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The EMA Turns 20: What Does It Want to Be?

Reflector looks at the growing pains of the European Medicine Agency (EMA) as it faces the key policy challenges of 2014. The European Medicines Agency (EMA) is 20 years old this year — and it confronts many of the problems familiar to anyone at that age. After the vigorous growth and boundless optimism of its […]
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Who's Watching the Drug Watchdogs?

It is nowadays fashionable to question everyone in authority, and there is no shortage of self-appointed watchdogs who aim to make sure that things that happen are happening as they should. The drug industry and drug regulatory authorities have been among the most conspicuous targets of this intense monitoring, on everything from questionable payments to […]
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EU Clinical Trials Rules: One Step Closer But Not Yet a Done Deal

By Peter O’ Donnell. To believe the European Parliament, the battle to create new clinical trials rules for the European Union is over. On January 22, the parliament’s health committee adopted the draft report prepared last year by one of its leading members. “Clearer rules, better protection for patients,” trumpeted the parliament’s press machine after […]
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