FDA Staffing Constraints Extend Planning and Review Timelines

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: How did reduced FDA capacity and staff turnover in 2025 most directly affect clinical trial planning and review timelines?

Paterson: It’s been a fascinating 12-month period at the FDA. I think the most direct impact of the current landscape of uncertainty has been extended timeframes in terms of planning for regulatory interactions, meetings, and decisions generally. That’s a very direct impact for organizations, but it also has a hidden effect.

Clients and organizations we’re speaking with are putting a lot more effort into preparation for meetings—whether that’s planning longer timelines in advance, investing more effort and energy into submissions to ensure as much clarity as possible, or submitting a more complete data file than they previously might have because they’re unsure of the feedback and guidance they’ll receive.

Commissioner Makary has set a very aggressive agenda, which is exciting to see. He’s focused on pace, AI integration, and the right priorities. But losing roughly 20% of staff in a year makes it difficult to sustain progress. Some institutional knowledge has been lost, particularly in certain therapeutic areas.

That creates real challenges. The depth of feedback organizations can get on innovative study design and primary endpoints is harder to access early enough in the process, and that elongates timelines. We’re seeing direct delays—responses taking longer, meetings being pushed back—but also increased upfront investment that makes it take longer to reach those meetings in the first place.