Upcoming 11/3/2014 FDA-DOC Meeting; Concerns About FDA Biosimilar Guidance(s)

At this point, I don't think its really necessary for me to repeat too much of the content that is already circulating within the diabetes online community of blogs about the forthcoming Monday, November 3, 2014 meeting  from 1:00 pm-4:00 pm ET with the U.S. Food and Drug Administration (FDA).  But I WILL say that collectively, over the past year, the diabetes patient community was able to accomplish something truly quite extraordinary.  You should know about that, and even better, you also have a chance to participate in that!Specifically, in 2013, the diabetes online community started a petition (see http://www.change.org/p/us-food-and-drug-administration-sponsor-a-patient-meeting-on-diabetes), which asked the FDA to devote one of its planned public meetings to diabetes.  For those who don't recall or never heard the sordid history, the short story is that back in 2012, FDA announced that over the next five years, it would be conducting at least 20 meetings on various conditions ranging from Chronic Fatigue Syndrome to Narcolepsy to Irritable Bowel Syndrome.  FDA pre-selected the diseases it would address in the first half of those meetings, yet miraculously, FDA did NOT originally plan to hold a patient meetings to discuss diabetes.  There were only four remaining slots open, and that's where we as a patient community came in.  The basic idea is that such a meeting would help to identify what barriers still exist that prevent the most eff...
Source: Scott's Web Log - Category: Endocrinology Tags: biogenerics Biosimilar diatribe FDA hypoglycemia Lantus Lilly Sanofi Source Type: blogs