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....
View ArticleThe 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,...
View ArticleFederal 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...
View ArticleFDA 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...
View ArticleEating 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...
View ArticleYou Got Electronic Medical Device Reporting Questions?
The FDA has (some) answers read more
View ArticleResolving 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...
View ArticleFive 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...
View ArticleFDA 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...
View ArticleWhy 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
View ArticleWho 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...
View ArticleThinking Globally to Strengthen Science and Public Health Locally
FDA hosts summit to build a model for regulatory science and critical thinking read more
View ArticleFDA 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...
View ArticleFDA’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...
View ArticleMedical 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...
View ArticleMuch 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...
View ArticleThree 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...
View ArticleMedical 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...
View ArticleWhy 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...
View ArticleMedical 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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