It is generally assumed that an FDA approval is conditioned on the demonstrated safety and effectiveness of a product. However, when the FDA authorizes the use of a product due to an emergency condition, does that mean that there is no requirement to demonstrate safety and effectiveness?
Presumably the FDA has some regulatory threshold between "not proven safe" and "proven safe" where it issues emergency use authorizations. So, to what degree are safety standards relaxed when an FDA Emergency Use Authorization is used in lieu of a standard FDA approval?
Second question: while it is obviously that the relaxation of standards is influenced by the severity of the emergency, but does that relaxation threshold also vary with political and or corporate pressures?