Before all this talk of “Snowmaggedon”, a beaming headline posted late last week stating that, “FDA Issues Guidance to Help Streamline Medical Device Clinical Trials”.  If you were hoping to learn how it works, you were in for a statistics lesson on Bayesian methods for designing studies and analyzing clinical data.  (Wait, don’t leave!)  Good [...]

“How many should I take?”  “What level should I set my device to?”  “How long should I use the therapy?”  Many of these questions are answered in product labeling.  Labeling is all about specifying the “intended use” of the product.  The FDA has always enforced limits on labeling in all of its forms.  As the [...]

Before an hour had even passed, last night’s State of the Union address was already being analyzed and scrutinized in many different ways from a political standpoint.  Taking a closer look at the comments made by President Obama, it is interesting to see the implications this speech has for the continued health of the Medical [...]

Most Americans are starting to get their tax documents in the mail, and finding out just how much of their hard-earned income the state and federal governments have…and how much more they may owe.  It’s one thing when a tax is collected where you can see it.  So what about the hidden taxes out there [...]