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Insights from Mars’ and Dole’s Product Recalls

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Adverse food safety events can have disastrous effects on branding and profitability.

What the Heck’s Going On at the FDA?

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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.

Establishing a Patient Safety Culture, Part Two

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Editor's note: Part one of this three-part series on patient safety, "Establishing a Patient Safety Culture," offered an overview of the Juran Model for Pati

Establishing a Patient Safety Culture, Part One

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Ensuring patient safety is one of the most vital and challenging roles in health care.

FDA Deserves Better Treatment

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Speed up approval for new health care products and

FDA and EU Spar on Medical Device Regulation

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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.

FDA Introduces Triage Pilot Program

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During the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification submissions, aka

To Better Protect Patients, Health Care Needs More ‘Lean Thinking’

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As the Supreme Court debates the fate of “Obama Care,” we should recall the formal name of the law: the Patient Protection and Affordable Care Act (PPACA).

Medical Device CEO Laments ‘Anti-Industry’ FDA Culture

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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 d

Going Long in Medical Device Manufacturing

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Banner Medical is committed to an ambitious approach to quality assurance, one developed specifically for the evolving, critical needs of the medical device industry.

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