Biopharma leaders and commentators are publicly debating whether relations with the FDA have reached a breaking point after a wave of controversial regulator decisions, including the agency’s refusal to review Moderna’s flu shot. Industry speakers noted a shift from private negotiation to public criticism as companies cite moving goalposts on trial design and surrogate endpoints. The Post‑Hoc Live panel scheduled discussion will include reporters and analysts who have tracked recent disputes and broader agency changes under CBER leadership, focusing on how regulatory shifts affect trial planning, labeling expectations, and industry communications.