Slower FDA Guidance Pushes Sponsors Toward Legacy Approaches

In a recent video interview with Applied Clinical Trials, Charlie Paterson, partner at PA Consulting, discussed how reduced FDA capacity and significant staff turnover in 2025 have reshaped regulatory engagement and operational planning for clinical trials. Paterson explained that sponsors are facing longer timelines for meetings and decisions, prompting greater upfront investment in submissions and more conservative planning. He also outlined how slower FDA guidance is influencing trial design choices, limiting adoption of innovative approaches, and driving sponsors to rely on precedent and non-US regulatory frameworks. The conversation explored where regulatory uncertainty is most acute across the development lifecycle and how evolving risk tolerance at the FDA could further globalize clinical trial strategies.

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

ACT: What does a slower pace of new FDA guidance mean for operational decision-making in trial design and execution in 2026?

Paterson: I think it means organizations are relying more heavily on standards set outside of the US and on legacy knowledge. Sponsors want to rely on clear precedents where they can have confidence that the approaches they’re taking are more likely to be approved down the line.

At the same time, science and technology are moving very quickly, and the lack of timely guidance hinders progress. We have opportunities to embrace advances like real-world evidence, decentralized trials, AI, and digital endpoints, but those standards aren’t being advised on quickly enough in the US to allow sponsors to plan confidently.

From an operational standpoint, that means relying on approaches used over the past three, five, or even ten years. I’ve been part of discussions in D.C. where organizations are asking, “How can we move more quickly? How can we get confidence that if we adopt AI, we’ll still get therapies to market?”

Both sides are waiting for the other to move first. With so much at stake—patient need and investor expectations—organizations aren’t willing to take portfolio-level risks. As a result, we’re actually seeing a slowdown. Despite leadership’s desire to accelerate innovation, the effect is, in my opinion, the inverse.