You mentioned twice in your post that there is a legal requirement for at least one RCT.
Sorry but I have to call this out as this statement is FALSE. There is no legislation in existence that requires sponsors/manufacturers to conduct at least one RCT before FDA approval can be sought.
When submitting for regulatory approval in the USA or Europe manufacturers may decide to run non-randomised clinical trials involving comparisons against external controls used to support regulatory submissions, especially for diseases that are rare, with high unmet need, without approved therapies and/or where placebo is considered unethical.
If you want you can check out this free BMJ Journal article here: https://bmjopen.bmj.com/content/9/2/e024895. Hope this helps with your future analysis.
You mentioned twice in your post that there is a legal...
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