Dr Emil Kakkis' submission to FDA Brown/Brownback hearing, June 29, 2010
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Uploaded by DrTrevorMarshall on Jul 6, 2010
On 29/30 June 2010 the US FDA held a Public Hearing on how to improve the availability and processing of drugs in the rare diseases (called 'orphan drugs'). This hearing was mandated by the amendment moved by Senators Brown and Brownback to the 2010 FDA Appropriations Bill.
This is the submission made by Dr Emil Kakkis, of the Kakkis Every Life Foundation and CureTheProcess.org. He describes his experience with FDA drug designation processes, and explains why there is a need to 'CureTheProcess'
A written transcript of this presentation will be available, in due course, from www.regulations.gov
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