Cut IND Delays as FDA Chases China's 94-87 Lead

FDA wants to cut a year off the time from drug discovery to first-in-human dosing under HHS’s Operation TrialBlazer, announced June 22. Former regulators, not biotech executives, are the ones raising doubts about whether it’ll work.

The plan proposes a rolling submission process for investigational new drug applications, letting sponsors file IND components piecemeal and get feedback before submitting the whole package. Acting CBER Director Karim Mikhail told BIO 2026 that current IND guidance was never built for Phase 1 first-in-human filings.

The stakes: China’s NMPA approved 94 novel oncology drugs between 2020 and 2025, versus 87 cleared by FDA, according to a Health Affairs Scholar analysis. Health Secretary Robert F. Kennedy Jr. wants that gap closed.

Here’s the tell: FDA already tried mandating a single IRB for multisite studies back in 2022, as a formal proposed rule. TrialBlazer’s roadmap now looks to revive that proposal, requiring a single IRB for multisite studies, though attorneys note hospitals and academic centers may still resist giving up their own review authority.

Former oncology division director Harpreet Singh, now CMO at Precision for Medicine, says the IND was never the real bottleneck. Site activation, IRB review, and contracting eat the months, not FDA paperwork. Companies keep placing early trials in Australia and Europe because they’re faster and cheaper, she said, IND overhaul or not.

Public comments on the IND pilot closed July 22. Other TrialBlazer tracks stay open through September.

Sarah Chen