Reporting flagged legal and procedural concerns about the FDA’s new expedited drug program, including uncertainty about who must sign off on approvals and whether standard review steps can be bypassed. The article notes internal reluctance among some senior reviewers and instances where staff were told reviews could skip usual steps for certain products, prompting scrutiny from legal and regulatory stakeholders. The piece raises questions about institutional controls, accountability and the balance between speed and due diligence in approvals. Companies and policy watchers will monitor whether the agency issues clarifying guidance or adjusts governance to address sign‑off and auditability concerns.