Tag Archives: Regulatory

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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FDA Prohibits Another Ranbaxy Facility from Producing Drugs for US Market

FDA has reported that it notified Ranbaxy Laboratories, Ltd., on Jan. 23 that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January […]
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