FDA Commissioner Marty Makary publicly signaled forthcoming “deregulatory” actions, expanding on the agency’s recent relaxation of biosimilar trial requirements. Makary framed the steps as agency policy shifts intended to reduce barriers to market entry. The remarks have immediate implications for clinical development timelines, biosimilar competition and sponsors’ regulatory strategies; stakeholders are parsing which program areas—biosimilars, diagnostics, or expedited pathways—might be targeted next and how enforcement and post‑market surveillance will be adjusted.