A senior Food and Drug Administration official questioned longstanding external advisory committee processes as “costly” and slow, signaling an internal push to streamline review procedures. Separately, the CRO industry group ACRO urged the FDA to publish clear guidance before formally adopting a default one‑pivotal‑trial standard. Industry stakeholders including PhRMA have expressed cautious support for faster pathways but warn that formal guidance is needed to preserve scientific rigor. The two developments—an agency critique of advisory panels and calls for transparent rulemaking on single‑trial approvals—mark a deliberate regulatory shift toward expedited authorizations. One‑trial approvals would allow accelerations in some therapeutic areas but require updated standards for confirmatory evidence and trial design. Companies and CROs are pressing the agency for clarity to align development plans and manage regulatory risk.