Expedited Investigational New Drug Pilot Program; Request for Information

摘要

The Food and Drug Administration (FDA or the Agency) is opening 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. FDA is requesting information on the potential pilot program which would establish a network of qualified research institutions, such as academic medical c