December 28th, 2013

Homer Simpson "D'oh!"

FDA doesn't consider mortality to be an important outcome when approving new ABX

My notes are behind the cut. These ladies review some recent FDA approvals and critique the process. The upshot is that the FDA is fast-tracking drugs without following their own rules regarding the supposedly scientific and independent review process. My take: Don't Use New RX drugs until they've been on the market at least 10 years. Otherwise YOU are part of the longterm followup studies that they aren't doing before approval.

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