The FDA proposed a user‑fee scheme that would raise application fees for development programs conducting Phase I trials outside the U.S. under ongoing PDUFA negotiations. The agency said higher fees would incentivize anchoring early clinical development domestically and provide resources to speed review times, while reduced fees could be available for programs running Phase I trials in the U.S. Details remain under discussion, including criteria for fee reductions and payment timing; stakeholders warned the plan could shift global trial strategy and raise costs for companies using lower‑cost overseas sites. The proposal arrives amid broader FDA debates over trial requirements and trial efficiency. Biotech sponsors should prepare for potential budget impacts and model scenarios where higher early‑stage fees alter go/no‑go timelines or push more Phase I work back to U.S. centers.