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FDA explains rolling submissions and QRI partnerships to accelerate IND readiness
Summary
FDA staff described a rolling pre‑IND submission model where sponsor–QRI teams submit IND components iteratively to the agency, allowing issues to be resolved earlier and (agency said) reducing the need for post‑submission fixes while keeping the 30‑day IND clock intact.
Karim Mikhail, presenting the mechanics of the proposed pilot, said the rolling submission model lets sponsor–QRI pairs submit components of an IND as they are ready so the FDA can provide iterative feedback rather than waiting for a single pre‑IND meeting. "That's the biggest breakthrough here is that in the prior system, you know, you had to basically have most of your package ready to engage to speak to the FDA," he said.
Panelists explained that the rolling approach is intended to create a collaborative, iterative process: sponsor and QRI teams can meet with the FDA on individual components (CMC, nonclinical, clinical) as they are developed. While the formal 30‑day IND review period remains unchanged, the agency said dealing with most substantive issues before the formal submission should often reduce follow‑up meetings, clinical holds and downstream delays.
