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"Standard" Coronary Stent Trials Should Use PMA Data From Past Trials

This article was originally published in The Gray Sheet

Executive Summary

Coronary stent manufacturers with products already approved by FDA might consider releasing data contained in their premarket approval applications to serve as a replacement for the control arm for certain coronary stent trials, provided firms receive some level of compensation for the data and a certain amount of control over how they are used.

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