Perhaps if you have an example case that you know of you could post for discussion. As for SequestOx, it has has been so thoroughly discussed with the FDA, no questions remain.
There is a 2015 document but they did not address the same issues. However, we know the FDA is pressing to improve their processes even absent the issues on opioid abuse. I am no medical expert, my knowledge lies in business strategy. However, the events in the external environment are critical to understanding and assessing the opportunities a firm may have. So it is that I pay attention to the threats (all part of a simple SWOT).