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George E. P. Box Remembered

Statisticians recall the statisticians’ statistician On March 28, 2013, the world lost a person whom many consider to be a major contributor to the world of industrial statistics: George E. P. Box....

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The FDA Is Taking Its Act Abroad

And isn’t liking some of what it found The latest batch of Food and Drug Administration (FDA) inspection letters noting objectionable conditions, aka 483s, has a decidedly international flair: Italy,...

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Federal Regulators ‘Patent’ Another Bad Idea

Unexamined patent applications stack up due to filched funds The shell game called the federal budget added another nut recently as media reports revealed that during the last 20 years, approximately...

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FDA to Plug Holes in Medical Device Security Systems

It's depressingly easy to figure out hundreds of passwords The Internet giveth and the Internet taketh away. For years, we’ve been hearing about the benefits online tools will bring to the medical...

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Eating GMOs Isn’t Kosher for Anyone

Some indigestible facts you might not want to read over lunch What do China, Maine, Connecticut, Chipotle, and Whole Foods have in common? They all think you have a right to know whether the food you...

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You Got Electronic Medical Device Reporting Questions?

The FDA has (some) answers read more

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Resolving Disputes Concerning FDA and Medical Devices

FDA seeks comments on what constitutes a ‘significant decision’ Disagreements are inevitable in science, medicine—and even life. As part of a regulatory agency committed to public health, the Food and...

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Five Obstacles to Managing a Pharmaceutical Quality System, Part 1

Obstacle 1: Disconnect between cGMPs and the business Editor's note: This is the first in a five-part series exploring issues that affect management’s ability to detect the warning signals of current...

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FDA Publishes Guidance for Wireless Medical Devices

Maintaining the balance between innovation and safety Many medical devices today perform at least one function by using wireless technology to support health care delivery. In telemedicine, for...

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Why Product Life Cycle Is Critical in Medical Device Design Control

FDA auditors look for solid evidence of design control and tracking of all processes read more

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Who Is the Customer of Your Document?

A quality manual serves no purpose if no one reads it Arecent call with an old colleague from Europe got me wondering about a question that few are conscious of: Who is the customer of your quality...

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Thinking Globally to Strengthen Science and Public Health Locally

FDA hosts summit to build a model for regulatory science and critical thinking read more

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FDA Sponsors e-Learning for Evaluating Drug Promotion

Bad Ad program’s course and case studies help identify harmful and misleading ads You probably have seen many consumer advertisements for prescriptions drugs—on TV, in magazines, or online. Although...

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FDA’s Promises for 2014

For starters, increased international operations, and label enforcement Given the fact that the FDA probably doesn’t know what it plans to do in 2014, predicting their actions is challenging, to put...

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Medical Device Industry Identifies Problems with FDA’s UDI Initiative

Inconsistencies and hair-splitting with the term ‘required’ Let’s start with what most everyone agrees on: The Unique Device Identification (UDI) program is a swell idea. It gets a little trickier...

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Much Ado About SOTU

Analysis: No need for State of the Union analysis Those of us in and around Washington D.C. like to tell folks in the days leading up to a president’s State of the Union (SOTU) address that the...

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Three Things You Should Never Say When Presenting

How to get the decision or outcome you want PowerPoint is the devil’s instrument, and when you use it, you risk becoming a musician in his demonic orchestra. All of us are required to give...

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Medical Device Makers Urged to Play Nicer by Sharing Data

Speak up now, or don’t complain later You shouldn’t need Barney the giant purple dinosaur to remind you of the playground mantra “sharing is caring,” but maybe the medical device industry needs to do...

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Why FDA Supports a Flexible Approach to Drug Development

Increased flexibility doesn’t mean abandoning standards We all know that just as every person is different, so too is every disease and every drug. And so we weren’t surprised by the results of a new...

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Medical Device Industry Endures Tough 2013

2014 prospects aren’t much better It’s March 2014, but you could forgive medical device company leaders if they’re still smarting a bit from a generally tough 2013. Several new studies indicate a low...

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