[CodeWriter23]

Just so you know how the FDA works, they evaluate what Industry tells them to create their “Guidance”, subject to an open comment type of process. They’re not superheroes of science working in a perpetual adversarial stance against industry. They inspect companies to ensure regulated companies comply or are in the process of complying with the official Guidance.

Should industry players break rank and come up with science contradictory to the status quo, which challenges the Guidance. They’ll either start to notice and incorporate learnings into future Guidance revisions, or write up a Deficiency order against the company. The company can then defend itself by engaging further studies and/or litigation. AKA what the big players say is what goes.