Reporting has surfaced internal legal and procedural questions around the FDA’s new expedited drug program, including who within the agency is willing to sign final approvals and whether standard review steps have been bypassed for at least one product. Staff were reportedly told they could omit usual review stages in a specific instance, prompting concern about governance and accountability for accelerated pathways. The coverage highlights friction between the agency’s speed-to-patient mandate and the need for senior leadership sign-off and robust cross‑division review. Companies and investors should expect tighter scrutiny of decisions made under the program and potential policy or procedural clarifications from the FDA.