Two separate policy updates pointed to a more enforcement-led FDA posture affecting both review and promotion of therapeutics. One report described an FDA budget proposal including policy “wish list” items such as making pediatric priority review vouchers permanent and reshaping industry access to advisory committees. A second report highlighted increased OPDP enforcement activity, including scrutiny around promotional tone, imagery, and alignment between marketing claims and the evidence generated in clinical trials. For biopharma, the combined signals suggest companies should re-audit promotional materials and timing strategy while preparing for potential regulatory changes that could affect how pediatrics review incentives operate and how advisory inputs are structured.