U.S. aims to slash pre-IND timelines: Back to School 2026

The need to improve the efficiency of clinical research in the U.S., especially for early-stage trials, has been obvious for decades. So has the lack of progress. Global competition is finally pushing the government and private sector toward action, starting with the least contested steps: reducing the unnecessary work sponsors do before they file an IND.

FDA and other agencies, Congress, biopharma companies, and academics are converging on incremental but meaningful reforms that could cut the time required to launch first-in-human (FIH) trials. Clarifying and streamlining pre-IND data generation is moving from idea to action. ...