Content By Michael Causey

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By: Michael Causey

It’s no secret that Food and Drug Administration (FDA) inspectors hone in on a medical device company’s corrective and preventive action (CAPA) program during an inspection. But a leading CAPA consultant says many companies may have overreacted and made things unnecessarily difficult for themselves.

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By: Michael Causey


The latest batch of Food and Drug Administration (FDA) inspection letters noting objectionable conditions, aka 483s, has a decidedly international flair: Italy, Japan, and Canada had the pleasure of hosting FDA inspectors in recent months. Three firms were found wanting by the agency in a number of areas.

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By: Michael Causey


The giant sequoia trees on the Pacific Coast are breathtaking. Majestic and seemingly indestructible, they stand tall as a reminder that slow and steady sometimes does win the race. But what’s great in a forest isn’t always so great elsewhere.

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By: Michael Causey

A prominent politician goes before his constituents during a tough reelection campaign. He’s introduced by the local mayor, and strides to the stage, waving and smiling to enthusiastic applause.

“It’s great to be here with you tonight. I love this great state of [fill in the blank]. Erica and I miss being here, especially when we’re stuck in that snake pit called Washington, D.C.”

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By: Michael Causey

Turns out that some paranoid people have a reason to, well, be paranoid. Researchers from the London Business School issued a report last year finding that many people at work who thought they were being talked about were probably right.

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By: Michael Causey

There are two things right now that get relatively bipartisan support in Washington, D.C. The first is that a major league baseball team in D.C. won a pennant for the first time since we stopped huddling around our radios for entertainment. [Editor’s note: The Nationals lost in the first round of the playoffs. Sorry, Michael.] The second item is more up our alley: Americans should not be the victims of drug shortages, and something needs to be done about it.

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By: Michael Causey

The Cold War may be over, but apparently spying is still a growth industry. The latest spy-craft news comes from the seemingly staid Food and Drug Administration (FDA), which appears to have more George Smiley and John le Carré types than we’d ever imagined.

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By: Michael Causey

Sure, the Italians have better food, the English richer royal culture and accents, and French women don’t get fat, but we in America regulate medical devices better, don’t we? Not so fast, says the European Union.

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By: Michael Causey

While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the Food and Drug Administration’s (FDA) attempt to “force its own agenda” over dissenting science or how its own advisory boards vote on medical device classification is just part of a broader “systemic” problem with some at the agency.

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By: Michael Causey

Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should expect heavier regulation in 2012, and that will only increase if President Obama is reelected in November.

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