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FDA says pilot will test parallel IRB review to reduce post‑IND delays
Summary
FDA panelists said one goal of the expedited IND pilot is to run IRB review in parallel with rolling pre‑IND submissions so IRB approvals, contractual site arrangements and FDA 'safe to proceed' determinations align sooner, reducing post‑submission delays.
Karim Mikhail identified IRB timing as a key post‑IND bottleneck and said the pilot will test re‑aligning IRB review with the rolling pre‑IND process. "So we're gonna try to go back to that intent, which is try to run-in parallel the IRB review along with the IND submission," he said, noting some IRBs currently expect certain steps before review that slow the process.
Panelists described a scenario in which a draft clinical protocol is submitted to the IRB while pre‑IND rolling submissions continue, with sponsor, QRI, FDA and IRB coordinating to accelerate IRB approval, site contracting and other preparatory steps so a 'safe to proceed' from FDA comes close to concurrent IRB readiness.
