A senior FDA official publicly questioned the role and efficiency of advisory committees, calling some panels 'costly' and 'slow,' while industry groups such as ACRO have urged the agency to publish clear guidance on a proposed shift to single‑trial approvals as the default. The FDA’s recent statements—paired with Commissioner Makary’s policy shifts—are prompting calls from CROs and pharma for transparent rulemaking and sector engagement. ACRO requested formal draft guidance and stakeholder input before the one‑trial default expands beyond oncology, arguing that implementation should be deliberate. The regulatory debate raises practical implications for trial design, development costs, and approval timelines across therapeutic areas.