There is an Irish aphorism which states: "Anything that keeps a politician humble is healthy for democracy." The same might be said of bureaucrats. What sometimes strikes me as odd is that you can easily find coverage of the miscues of corporate America, but few media outlets are as punctilious about reporting on government's ill-intended moves. Here, then, are five reasons to mistrust government at least as much as device makers. Five: The Thompson Memo In 2003, this memo directed federal prosecutors to offer leniency to a corporate defendant if the defendant was willing to waive attorney-client privilege and/or willing...

First, just to let you know dear reader, this is a Casey Anthony-free blog posting. Those who are skeptical of the device industry in this world are legion, but there are a lot of reasons to cast the occasional baleful glance at government as well. What's interesting is how many in the media automatically assume that any clash between FDA and industry is necessarily the fault of industry. Case in point: I was at the American Diabetes Association annual scientific sessions about two weeks ago and had a conversation with another member of the press. She said more or less...

Washington is such a fun town, replete as it is with smoke and mirrors. It appears that despite my earlier protests about the mixed-up priorities where NIH spending are concerned, our elected officials are aware of the coming deluge of costs associated with Alzheimer's disease, but the latest legislation to address this disease, the National Alzheimer's Project Act (which goes by the cheery acronym of NAPA for you fans of wine and/or auto parts stores) seems to do little other than coordinate federal and state resources. According to a fact sheet posted at the website for the Alzheimer's Association (AA;...

SAN DIEGO – There were numerous discussions of new and developmental products at the 71st annual scientific sessions held by the American Diabetes Association (ADA; Alexandria, Virginia) in San Diego, a city which attendees might have deemed the fair weather capital of the lower 48. (Medical Device Daily)

SAN DIEGO – As noted in yesterday's edition of Medical Device Daily, the FDA guidance for low-glucose suspend insulin delivery systems is out and may foreshadow at least some of the content of a guidance addressing a full artificial pancreas. (Medical Device Daily)

SAN DIEGO – The 71st annual scientific sessions held by the American Diabetes Association (ADA; Alexandria, Virginia) commenced last Friday here in a somewhat different regulatory backdrop than last year thanks to FDA's release of a guidance dealing with a basic type of closed-loop artificial pancreas system. The meeting also followed in short order, however, an appearance on Capitol Hill by adolescent diabetics urging Congress to prod FDA into allowing more investigational closed-loop devices to move forward into clinical trials. (Medical Device Daily)