The FDA should not change its mind last minute

Note: Together with , , and , I have launched a Substack on Clinical Trial Abundance, where I also cross-posted this article. I often say that in drug development, lack of regulatory clarity and consistency can be more damaging than regulation itself. Clear rules, even when stringent, can be understood and navigated. But unclear or constantly shifting expectations can be much harder to efficiently deal with.This uncertainty has the very pernicious effect of reshaping behavior across the biotech ...