WASHINGTON, June 24 -- Food and Drug Administration has issued a notice called: Expedited Investigational New Drug Pilot Program; Request for Information.
The notice was published in the Federal Register on June 24 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: 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 ne...