Contract research organization group ACRO urged the FDA to issue formal guidance and open notice‑and‑comment rulemaking before expanding a new default that a single adequate trial plus confirmatory evidence can support marketing authorization. The plea follows the agency’s public shift away from the two‑trial dogma and intensified debate with industry groups calling for transparency. Concurrently, a senior FDA official criticized advisory committees as costly and slow, prompting concern about diminished external scientific input. Together, these developments underscore friction between the FDA’s effort to streamline approvals and stakeholder demands for predictable, consultative regulatory processes.