The FDA’s 2027 budget proposal would make the rare pediatric disease priority review voucher program permanent and introduce a new “clinical trial notification pathway” to ease entry into Phase 1 studies. The plan would increase the FDA’s budget by more than $200 million to over $7 billion in 2027, with funds intended to shift the agency toward more proactive oversight. Under current practice, the priority review voucher has required periodic Congressional renewal, with a gap that led to sunset implementation after September 2024, and restarting in September 2025. The proposal is framed around predictability for sponsors while maintaining incentives for pediatric rare disease development. The budget also links “radical transparency” goals to regulatory reforms, and describes reducing reliance on the Investigational New Drug application pathway for certain trial starts through a notification mechanism, according to the proposal document.