FDA Drug Reviews Held Steady in 2025 Despite Historic Staffing Losses
A new data study reveals what we've seen firsthand: the FDA isn't slowing down reviews even after trimming its staff significantly.
Source: Endpoints News analysis by Zachary Brennan (Jan. 8, 2026)
Despite unprecedented staffing losses across the FDA’s drug and biologics centers in 2025, the agency largely maintained its new drug review timelines — something we’ve observed firsthand ourselves, having facilitated hundreds of review interactions with clients over the past 12 months.
An Endpoints News analysis of all 53 novel drugs and biologics approved in 2025 found that FDA reviewers met nearly all user-fee (PDUFA) commitments, even as thousands of staff exited the agency through retirements, leadership departures, and reductions in force.
Only two applications exceeded a 12-month review timeline after being accepted for review, and in both cases, the delays were tied to the FDA extending review periods to assess newly submitted data, not internal resource constraints.
What the approvals data shows
An infogram chart of FDA novel drug and biologic approvals shows that the number of drug and biologic approvals is more or less in line with variances over the past few years, no dramatic drop-off.
The study also found:
Most approvals clustered within standard review windows. Most 2025 approvals occurred within the typical 6–10-month FDA review period, consistent with historical norms.
Expedited pathways continued to perform as expected. More than 20 new drugs were approved in eight months or less, reflecting continued use of priority review and expedited programs, including approvals following resubmissions.
No visible “approval bottleneck” in 2025. The distribution of approval timelines does not show a meaningful shift toward longer review durations, even as staffing turbulence intensified behind the scenes.
Taken together, the data suggest that (operationally) FDA review divisions were able to absorb significant workforce disruption without immediate downstream impact on approval timing.
Fewer approvals, but not slower reviews
All that said, the FDA approved fewer novel drugs in 2025 than in 2023 or 2024, falling short of public expectations set earlier in the year. While review timelines held, total output declined a bit.
A Jefferies report (Jan. 3, 2026) cited by Endpoints similarly found that approval and rejection trends remained in line with historical norms, undercutting claims that reduced FDA headcount has already slowed one of the agency’s core functions.
Early signs of strain are emerging
While headline timelines held, subtle warning signals are beginning to appear.
An RBC Capital Markets analysis found that 78% of drug approvals (new and supplemental) in the second half of 2025 were completed on time, down from a historical range of 85–90%.
RBC analysts attributed the dip to short-staffing following early-2025 HHS cutbacks and personnel changes, not to a shift in the FDA’s regulatory posture or permissiveness. Importantly, they did not suggest delays on the scale of years, but they did flag capacity risk.
Historic staffing losses underpin the risk
Those capacity concerns are reinforced by FDA hiring and attrition data, also reported by Endpoints.
According to FDA figures:
CDER lost 746 staff in Q4 FY2025, gaining just six.
CBER lost 194 staff, gaining four.
In total, nearly 1,000 net departures occurred in the final quarter of FY2025.
All net staffing gains from 2023 and 2024 were erased — and then some.
Neither CDER nor CBER has ever recorded net losses at this scale in a single fiscal year. And it remains unclear whether publicly reported figures fully capture the more than 3,000 FDA staff impacted by the agency-wide RIF.
What this means for sponsors
For now, the data support a clear conclusion:
FDA’s drug review engine held together in 2025 — but it is operating with far less margin for error.
Sponsors should not assume:
that current timelines are guaranteed going forward, or
that resource strain won’t surface in more frequent information requests, extensions tied to new data, or uneven performance across divisions.
As 2026 unfolds, attention will increasingly focus on whether the FDA can sustain the review pace without further erosion, especially if attrition continues or workload increases. We’re watching this closely and will keep you updated if and when we see things change.
This piece synthesizes Endpoints News reporting and analysis by Zachary Brennan, including “2025’s huge FDA staff cuts mostly didn’t impact new drug review timelines” and “FDA staffing data show historic numbers of departures in fiscal 2025.”
Talk to us if you need FDA application or submission support heading into the new year.
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