Authored by Eyal Wultz, Bioforum Co-founder and BionData Co-founder and President
Over the past few years, FDA warning letters have been rising fast—nearly doubling since 2022. But what’s driving this surge?
To find out, I analyzed the 550+ warning letters issued between 2022 and May 2025 by CDER, CBER, and CDRH[i]. I wanted to understand whether this increase reflects heavier regulatory workload, shifts in enforcement priorities, or something deeper.
The data pointed to a clear and unexpected pattern – one that tells us a lot about what regulators are really focused on right now.
Let’s dive in.
Let’s Look at the Scorecard
Here’s the year-by-year increase in total warning letters:
The 2025 number is a projection based on the 97 letters issued by mid-May, extrapolated to the full year using a conservative growth rate in line with previous trends.
That’s an average annual growth of 25% in warning letters. But if you think this is just due to heavier regulatory workload, think again.
The Workload Isn’t Going Up
In fact, the number of submissions has been stable or declining[ii]:
Therapy approvals? Also steady[iii]:
So if the number of applications isn’t climbing, what explains the surge in warning letters?
Data Integrity: The Top Red Card Offense
When I filtered the letters for phrases like “data fabrication,” “unreliable data,” “missing data,” “data traceability”, “data integrity,” or “manipulated data” the trend was unmistakable[iv] :
That’s 40% annual growth—outpacing the overall rise in warning letters. Just look at how the proportion of letters citing data integrity issues has increased year over year:
This isn’t just a spoke – it’s a signal.
A Global Problem Red Card
This isn’t just a U.S. concern. A joint FDA-EMA study published in 2022, based on 49 global GCP inspections, revealed that both agencies consistently flagged similar deficiencies[iv]. The recurring issues centered around how trials were managed, how closely protocols were followed, and how well data and documentation were maintained. In other words, data integrity lapses aren’t isolated—they’re a global pattern.
What This Means for You
Think your data package is submission-ready because you checked all the boxes? Think again. If your submission lacks integrity—if data traceability, accuracy, and completeness aren’t built in from day one—you’re walking into the game with a yellow card already. And regulators won’t hesitate to show red.
Up Next
In our next blog post, we’ll explore why regulators are cracking down so hard on data integrity—and what it means for sponsors, CROs, and data vendors alike.
Stay tuned—and play clean
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Resources
[i] FDA Warning Letter Search Engine
[ii] 2023 PDUFA (the FDA Prescription Drug User Fee Act) Performance Report
[iii] FDA “New Drug Therapy Approvals 2024” report; Propharma Illuminating FDA’s 2023 BLA Approvals: A Comparative Analysis; FDA “2024 Biological Approvals”, FDA Prepmarket Approval (PMA) database
[iv] https://trpma.org.tw/eng/news/news_4984