Split Real Time Application Review (STAR) (from Catapult's regulatory round-up for November 2024)

Under the Prescription Drug User Fee Act (PDUFA) VII Commitment, FDA is creating the STAR pilot program which aims to shorten the time from the date of complete submission to the action date, in order to allow earlier patient access to therapies that address an unmet medical need. FDA will consider an application eligible for the STAR pilot program if each of the following criteria are met: Clinical evidence from adequate and well-controlled investigation(s) indicates that the drug may demon...