does the fda's rulebook for animal drugs hide a shortcut for our rarest human medicines?
a human drug can, in narrow cases, win approval on animal efficacy data 21 cfr 314.600–650 (the "animal rule") · fda · §314.610 alone, when a human efficacy trial would be neither ethical nor feasible. the question this trail digs: where does that seam actually connect to the orphan-drug incentive structure orphan drug act, 21 usc §360aa–360ff · designation criteria, and where does everyone assume it connects but it does not?