Abstract This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments fo... https://www.roneverhart.com/Tzora-Titan-and-Hummer-Battery-Pack-with-Plastic-Casing-2-Batteries/