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FDA details metrics for expedited IND pilot and selection timetable
Summary
FDA said it will measure pilot success by reductions in clinical holds, time from defined pre‑IND points to FDA may‑proceed letters, and time from IND submission to first patient in; agency staff also said QRI submission quality will be a key success factor.
Panelists listed concrete success metrics for the expedited IND pilot, including the rate of full clinical holds after IND submission, the time from submission to first patient in, and a defined measure of pre‑IND time to a regulatory 'may proceed' letter. Mike Davis said these metrics will help determine whether the rolling approach reduces downstream delays without weakening safety protections.
Karim Mikhail added that QRI quality will be central: robust, expert regulatory advice from QRIs should lead to more complete submissions and fewer follow‑up issues at FDA. "One of the things we'll be looking at is the recommendations and the submissions that we get from the pair and how successful and complete they are," he said. FDA reiterated it will analyze RFI comments and finalize selection criteria and timelines prior to opening applications in September.
