July 31, 2010drug safety

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The Case For Outreach

Stopping Drug Safety Spin Cycle

October 12, 2007

A few years ago, thinking the way all journalists think, we had an epiphany. The reportorial brain is the one we’re happily stuck with. But it often adopts a harshly negative, critical outlook that transcends age, geography and political affiliation. We resolved to outgrow that outlook. Then, as luck would have it, we met a few journalists (at our old haunt, Bio-IT World) who saw the world a bit less darkly. Don’t get us wrong. It’s not that there is anything wrong with dark. We love dark. But with that world view, a journalist can miss other stories, which is an occupational handicap. Three Types of Companies The standoffishness of the pharmaceutical industry is a similarly troublesome quality. A certain aloofness is placing the life sciences in a shady reputational neighborhood. What do we mean? Have a peek at our chart. In the old days, there were two types of companies.…more...

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A Chance To Give Back

Toward A Global Safety Network

September 10, 2007

There is an article in the British Medical Journal related to international aspects of drug safety in the developing world. “Pharmacovigilance in the Developing World,” written by researchers in England and…more...

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New Tools, More Trials?

Radical Drug Safety Shift

March 29, 2007

It’s impossible to predict how the PDUFA issue will play out this year. But the House bill 1561 has a number of interesting provisions. It was introduced last week by Henry…more...

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'Sentinel,' Other Tools Planned

FDA Outlines Major Safety Overhaul

February 01, 2007

FDA head Andrew von Eschenbach has proposed a partial adoption of Institute of Medicine recommendations about drug safety. The Duke Clinical Research Institute and Mortara Instrument (a European electrocardiogram firm) have…more...

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Rethinking Everything

Drug Safety Landscape Shifts

February 01, 2007

Like the aftershocks from an earthquake, the political tremors after Vioxx don’t seem to subside. Yes, Merck’s strategy of swatting the pesky plaintiff lawyer-flies one at a time seems to be paying off. And yes, the FDA’s attempt to bolster its own drug safety efforts can now be pondered by a predictably divided and intemperate Congress. But…more...

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Funds for IT, post-marketing, safety

FDA: Raise PDUFA Fees 29 Percent

January 15, 2007

FDA has released a plan for enhancing drug safety. To pay for it, the agency has proposed a 29 percent rise in spending for a renewal of the Prescription Drug User Fee Act (PDUFA), from $304 million to $393 million. By definition, of course, such fees would be charged to the industry. FDA is suggesting $87.4 million…more...

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