By
AmyT on
November 3, 2010
Why is affordable generic insulin not available to patients in the US? Mainly because the big manufacturers have a stronghold on the patents for this complicated “biologic” drug. But now it seems Big Pharma itself may be presenting a nice alternative.
What I’m talking about is Pfizer’s new attempt to enter the injectable insulin market (less risky than their Exubera flop!) Pfizer and Biocon, a biopharmaceutical company in India, recently announced a multimillion dollar partnership…
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By
AmyT on
March 24, 2010
More details on the recent FDA Hearings on the accuracy of blood glucose monitoring devices: I was surprised by the report from patient advocate Ellen Ullman on Monday, noting that patient interests seem to be grossly underrepresented, and lots of experts seem to believe that the status quo of +/- 20% error margin is all that any of us need (or can handle). Grrrrr….
See Dear FDA over at “Your Diabetes May Vary” for an…
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By
AmyT on
March 22, 2010
Many of you may know that the FDA held a two-day Public Hearing on the issue of Glucose Meter Accuracy late last week. Dozens of experts gathered at the Washington DC Hilton/Gaithersburg Hotel to lend testimony.
The issue at hand, according to FDA statements, is that:
“Glucose meters are increasingly being used to achieve tight glycemic control despite the fact that these devices have not been approved for this use. There is currently no consensus…
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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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The New York Times reports today that the rise in the use of home glucose monitors, also in hospitals, is pushing the Food and Drug Administration toward a possible crack-down on accuracy standards. Some of you might say it’s about time, considering that current standards allow a margin for error of up to 20%, which can make a huge difference in the choices we make on food, exercise, and in particular insulin doses.
And who…
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