HHS unveiled a blueprint to speed up early-stage drug development, targeting first-in-human timelines by reducing documentation burden for Investigational New Drug (IND) applications and creating options for rolling submissions and protocol adjustments. The plan also explores whether trial-enrollee stipends could be permitted under federal anti-kickback rules. The Department of Health and Human Services said the effort is aimed at relieving pressure on biotech companies preparing to start clinical trials, especially as U.S. developers face faster timelines from overseas competitors. It includes FDA guidance on what data is necessary before IND filing and a pilot concept for consultations with research institutions during IND preparation. Separately, FDA is revisiting its approach in rare-disease gene therapy, with Regenxbio set to resubmit after regulators reversed positions tied to comparator and endpoint expectations for its Hunter syndrome therapy. The company said FDA staff acknowledged existing clinical data as sufficient for an accelerated approval pathway, potentially shortening the path to a new review. Together, the moves underscore a regulatory push for faster proof-of-concept testing while refining what constitutes adequate evidence for first approvals—particularly where patient populations are small and trial designs are difficult to execute.