By
AmyT on
December 2, 2011
Yesterday marks “a milestone” in the development of new technology to help automate the care and treatment of type 1 diabetes, according to JDRF!
The U.S. Food and Drug Administration unveiled its eagerly awaited Draft Guidance document for research and development of the Artificial Pancreas system, and initial reaction from JDRF — in a press conference held yesterday afternoon — was a mix of jubilation and a more measured response that they remain “guardedly optimistic” about the details…
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By
AmyT on
November 29, 2011
Ten days ago, I got a last-minute invitation to attend a small Bay Area JDRF event at the Four Seasons Hotel in Palo Alto, in the heart of Silicon Valley. This is where technology happens. It turns out, this diabetes-tech-update event has been going on for a few years. I was especially excited, because the theme of this year’s program was FDA Reform: How Can We Remain Competitive While Protecting Public Safety? Now that sounded…
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By
AmyT on
December 10, 2009
Many of you know that the FDA held public hearings on the pharma industry’s use of Social Media mid-last-month. There was much excitement going into this because to date, the FDA has pretty much dodged the subject, and left drugmakers in fear of retribution (see BusinessWeek‘s summary here).
Essentially, since there are no clear rules laid out for how pharma can and can’t advertise their wares online, and talk about them on blogs, social networks,…
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By
AmyT on
December 11, 2008
There are a lot of things going on at the troubled Food and Drug Administration right now that could have a profound impact on the future of diabetes care, but most of us patients never hear about them. And that’s a damn shame. Because we stand at a crossroads.
You may or may not be aware that the Obama Administration is about to appoint a new FDA Commissioner. The politics and personal leanings of this…
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