FDA advisory committee meetings are back on the calendar under new leadership, with renewed emphasis on panels for contested product applications. Two announced meetings—covering Replimune and Capricor—signal that disputed evidence packages are likely to face heightened scrutiny. The coverage points to Replimune’s Replimune and Capricor meetings as revisiting earlier controversies tied to prior FDA leadership. The updated process is expected to bring further public discussion around efficacy and evidentiary adequacy for applications under debate. Regulatory observers will watch how the advice framework evolves as officials explicitly use advisory committees to pressure-test complex submissions. For developers, the message is direct: contested applications may be harder to move forward without panel-level consensus or clear corrective pathways.