The FDA launched a pilot program that pairs drug sponsors with prequalified research institutions to expedite Phase I IND preparation and reduce delays to first-in-human studies. Under the program, once paired, sponsors and sites can file trial plans on a rolling basis during the pre-IND phase rather than waiting for all components to be ready. The agency said the QRIs selected for the pilot will bring specialized scientific expertise to support IND application preparation and review acceptance of individual components. Applications are accepted until Oct. 30, with eight to 10 projects expected to be selected.
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