Thursday, December 08, 2016 9:18:14 AM
RWD says all that RWD can say. The FDA wants to "consider" RWD but it's not clinical data and it's barely science, and the FDA's job is to evaluate clinical data and interpret science.
Without controls and blinds, how does the FDA know that a person who says they got good results from an ActiPatch knee wrap wasn't just getting good results from (a) placebo effects and/or (b) the knee wrap?
When your knee or back or ankle or elbow or wrist hurts, wrapping it reduces the pain.
Have a spectacular day.
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