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Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period

Notice πŸ’¬ Comment by Aug 24 (26d left)
Health and Human Services Department, Food and Drug Administration
Notice
July 21, 2026
2026-14672
August 24, 2026 (26 days left)

πŸ“„ Summary

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of June 24, 2026, to open a public docket to solicit input and comments on a proposal to establish a pilot program, the Expedited Investigational New Drug (IND) pilot program, to shorten the time it takes from drug identification to first-in-human (FIH) study, while protecting clinical trial participants.
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