FDA launches expedited IND pilot, fills in details on its design
FDA has opened its expedited IND pilot, moving forward with an initiative designed to test new approaches to accelerating first-in-human clinical research in the U.S. The program will pair selected sponsors with qualified research institutions and explore approaches including rolling IND submissions.
Beyond the initial pilot, the effort could offer important signals about how FDA is thinking about the future of early-stage drug development and broader clinical trial reform.
This AgencyIQ analysis examines the pilot’s design, the questions still to be answered and what its results could mean for future FDA policy.
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