Industry and clinicians are contesting a sharper FDA posture on accelerated approvals and post‑market expectations. BioCentury flagged tensions between the agency’s accelerated approval messaging and an uptick in complete response letters (CRLs), pointing to recent examples where surrogate endpoints and trial comparators drew regulatory pushback. Separately, a group of around 1,000 physicians publicly urged the FDA to reverse a CRL for a myopia drug, arguing the program met endpoints specified by the agency. The petition underscores a broader friction: clinicians and developers say accelerated pathways are vital for unmet needs, while some regulators and reviewers are increasingly skeptical of surrogate‑driven approvals. Clarification: a CRL (complete response letter) indicates FDA review concluded the application cannot be approved in its present form; accelerated approval allows conditional market access based on surrogate or intermediate endpoints requiring confirmatory trials. The debate is driving companies to reassess evidentiary strategies and could lengthen development timelines.