KP, In my opinion you are placing an incorrect interpretation on what PoS said.
I say this because the FDA does not "approve" trials. They have neither the interest nor the procedural structure for such a thing.
The 22 trials that PoS refers to were all conducted in accordance with published FDA guidance for the conduct of trials of various types, and I think that is the point he was making.
Of course, PoS can speak for himself if I have this wrong.
chart update, page-155
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