Industry groups call for clearer FDA guidance on QRIs in expedited IND pilot

Pharmaceutical trade groups have voiced concerns about the FDA's proposed expedited IND pilot, which aims to speed entry of drug candidates into first‑in‑human studies.

The groups say the FDA needs to issue clearer guidance on how qualified research institutions (QRIs) will be involved, noting that ambiguity could affect planning and collaboration.

They argue that precise rules are essential to ensure the pilot achieves its goal of reducing timelines without compromising safety or regulatory oversight.