[pdkl95]

> (without intention of standards-body registration) as long as the prescribing doctor is willing

Unfortunately, the doctor (or scientist) cannot be allowed to make that decision on their own. There are far too many terrible examples in the not-very-distant past where doctors testing a new type of treatment drifted away from legitimate research into unethical experimentation[1], patient abuse, even torture and eugenics. Yes, most doctors wouldn't but the unusual-long length of the Wikipedia page [1] is why it's important to say "this is why we can't have nice things" require external approval.

That said, this approval are primarily concerned with preventing unethical experimentation and limiting the damage when the testing goes horribly wrong. Oversight of ethical issues and experimental technique should, in theory, be a lot simpler[2] and cheaper than the higher standard of proving that a new drug is "safe enough".

[1] https://en.wikipedia.org/wiki/Unethical_human_experimentatio...

[2] I know IRB approval isn't going to be "simple" for any type of experiment involving humans. It's easier than getting full FDA or EU approval.