Finally, we see things stirring

It is quite clear that the present requirements for drug approval have been sluggish and are in dire need of revamping.
It appears that there may be some changes coming about:

The TREAT Act allows FDA to tap into modern scientific advances by using a broad range of surrogate or clinical endpoints and modern scientific tools earlier in the drug development cycle, when appropriate, to approve treaments for patients. Employing these modern scientific tools may result in fewer, smaller, or shorter clinical trials for the intended patient population or targeted subpopulation without compromising or altering FDA’s existing high standards for the approval of drugs.