Tag Archives: FDA

Leverage: A tale of three struggles for power

We all know power struggles are part of life, but not all struggles for leverage are created equal. Following are three stories that tell us something about leverage and its many uses. Interagency conflict over Intermacs? The Centers for Medicare…

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Trust in government: 23 more reasons for suspicions

The number 23 is an interesting number. It’s a prime number, and is the number of pairs of chromosomes in human DNA, but it may also become a number FDA won’t soon forget. FDA recently issued a warning letter to…

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Thanksgiving: There’s more than one kind of turkey

‘Tis the season to be thankful and slice into a roasted turkey with family and friends. In the spirit of the occasion, here are a few things I’m thankful for, and a few turkeys I think we could all do…

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Government, industry and crossed wires

The playwright George Bernard Shaw is credited with having said, “the single biggest problem in communication is the illusion that it has taken place,” a remark device makers might apply to their interactions with FDA and the Centers for Medicare…

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FDA or optimism: The worst of all possible worlds

A story of bureaucratic overreach, clinical trial data disclosure, and Washingtonian flights of fancy with a tip ‘o the hat to Voltaire. In a castle of Silver Springalia, belonging to the Baron of Our-Way-or-the-Highway, lived an industrious youth endowed with…

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Mal-fee-sance; The FDA user fee controversy

If you like controversy, a job at FDA would be right up your alley, but it’s tempting to think some of these controversies are contrived. The question of the influence of user fees on FDA reviews has surfaced (yet again),…

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The hunt for a green October

A cynic’s guide to the galaxy might suggest everyone in healthcare is in it strictly for the money, but it’s tough to tell. After all, what can you do without the stuff? Even FDA and NIH are constantly clamoring for…

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I’ve got 99 problems but a CT scan isn’t one of ‘em

As a proud father of a two-year-old little girl, it’s always stories the stories about children that grab my attention the most. Take for instance, a recent one that I wrote, discussing the risk of radiation-induced solid cancers in older…

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Double trouble: Two firms under FDA’s microscope

A lot of warning letters and other FDA enforcement action are addressed to obscure companies, but lately a few big names have come under scrutiny. In a recent posting here at MDD Perspectives, we addressed a warning letter to Edwards…

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Life science confidential? Not lately

We all know there’s no such thing as a free lunch, but what’s not always clear is the cost. The U.S. federal government in two of its incarnations recently put those in the life science industries on alert that the…

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