FDA’s Patient Skills: One Year Later
This article was originally published in RPM Report
For over a year since initiating patient-focused drug development meetings under PDUFA V, FDA drug review managers have been reviving their bedside-manner. FDA has invited the patients into the drug development process; that invitation carries with it the obligation to adopt a different tone and workplace style. Some of the first meetings showed that senior FDA review staff were a little out of practice in relating to patients; the most recent efforts show substantial progress.
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