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# FDA Staffing Shortages are Lengthening Trial Planning
- URL: https://www.fdaweb.com/fda-staffing-shortages-are-lengthening-trial-planning/
- Published: 2026-01-29T12:00:00.000Z
- Updated: 2026-09-14T15:31:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160568

Reduced FDA staffing levels and high turnover are extending regulatory timelines and forcing drug developers to invest more heavily in upfront planning, according to an industry consultant. In a [recent interview](https://www.appliedclinicaltrialsonline.com/view/fda-staffing-constraints-extend-planning-review-timelines?ref=fdaweb.com) with *Applied Clinical Trials*, **Charlie Paterson**, a partner at PA Consulting, said sponsors are facing longer wait times for regulatory meetings and decisions as the agency continues to operate with reduced capacity following significant staff departures in 2025.

“It’s been a fascinating 12-month period at the FDA,” Paterson said. “The most direct impact has been extended timeframes in terms of planning for regulatory interactions, meetings, and decisions generally.”

Paterson estimated that the FDA lost roughly 20% of its staff over the past year, creating gaps in institutional knowledge, particularly in certain therapeutic areas. While FDA commissioner **Marty Makary** has outlined an ambitious agenda focused on accelerating review timelines, integrating artificial intelligence, and prioritizing key programs, Paterson said staffing constraints are making those goals difficult to sustain in the near term.

The delays are having both visible and less obvious effects on drug development programs. Paterson said sponsors are responding by building longer timelines into their development plans and dedicating more resources to regulatory submissions to compensate for slower feedback from the agency.

Companies are submitting more complete and detailed data packages earlier than in the past, he said, in an effort to reduce the number of follow-up questions and minimize uncertainty around FDA expectations.

“There’s a hidden effect,” Paterson said. “Organizations are investing much more effort and energy into preparation because they’re unsure what guidance they’ll receive and how long it will take to get it.”

The slowdown is also influencing clinical trial design decisions, particularly during early development. Paterson said sponsors are becoming more cautious about proposing innovative study designs or novel endpoints, given the difficulty of obtaining timely FDA input. As a result, some companies are leaning more heavily on established precedents or looking to non-U.S. regulators for earlier guidance.

The combination of delayed responses, postponed meetings, and increased preparatory work is extending development timelines at multiple points across the clinical lifecycle, Paterson said, with early planning stages among the most affected.

While industry observers expect some stabilization as FDA rebuilds capacity, Paterson said uncertainty around review timelines and regulatory risk tolerance is likely to persist in the near term, potentially accelerating the globalization of clinical trial strategies as sponsors seek clearer and faster pathways outside the U.S.