The FDA proposed restructuring user fees to incentivize companies to run early‑stage clinical trials in the U.S., floating lower fees for domestic early‑stage work and higher fees for sponsors that conduct Phase 1 trials overseas. The concept surfaced during PDUFA reauthorization discussions and is meant to shore up U.S. early development activity. Meeting minutes and agency summaries show the FDA also considered recurring fees for companies that innovate abroad after filing an IND, as well as operational questions about criteria and payment timing. Industry representatives asked for details on implementation and the expected impact on small companies and global development strategies. Sponsors and trade groups will engage in the PDUFA negotiations; if adopted, the fee changes could alter where early clinical development is staged and affect capital allocation decisions for early‑stage biotechs.