What a 50% Increase in FDA CDER Warning Letters Tells Us About Quality, Oversight, and System Pressure

According to remarks reported by the Regulatory Affairs Professionals Society, the FDA Center for Drug Evaluation and Research (CDER) issued 50% more warning letters in fiscal year 2025 than in the previous year. This is a notable increase and suggests a change in enforcement activity that warrants closer examination. Whether this reflects a shift in regulatory posture, changes in industry behavior, or increased scrutiny of emerging areas remains an open question.

Rather than treating this figure purely as a headline about enforcement intensity, it is useful to consider what such an increase may indicate about where regulatory attention is currently focused and how oversight adapts as technologies, business models, and supply chains evolve.

Enforcement volume as a signal, not just an outcome

Warning letters are often viewed as the final step in regulatory enforcement. From a systems perspective, they can also be understood as lagging indicators. By the time a warning letter is issued, inspections have occurred, observations have been documented, and responses have been reviewed. Escalation typically reflects a judgment that identified issues were not adequately addressed.

A sharp increase in warning letters therefore raises a broader question:

are regulators encountering more instances of noncompliance, or are they applying closer scrutiny to areas where compliance expectations are still being interpreted and tested?

Concentration of enforcement activity

The breakdown reported by CDER suggests that the increase is not evenly distributed. Manufacturing GMP violations, misleading marketing of compounded products, unapproved drugs, and bioresearch-related issues are all familiar categories. What appears to have changed is the concentration of enforcement activity, particularly in areas associated with newer delivery and marketing models.

This pattern suggests that enforcement is responding to where regulatory boundaries are most actively being explored, rather than signaling a uniform deterioration in quality across all regulated domains.

Telehealth, compounding, and emerging oversight challenges

One of the more prominent data points is that 22% of CDER warning letters in FY 2025 were issued to telehealth platforms making false or misleading claims about compounded products, including GLP-1 agonists.

These activities sit at the intersection of:

• rapidly evolving digital business models,

• high patient demand,

• regulatory frameworks originally designed for more traditional care settings,

• and quality systems not always adapted to platform-based operations.

From a project and quality management perspective, this suggests that new technologies and delivery models may require heightened regulatory attention, particularly when speed of deployment outpaces established governance mechanisms.

Manufacturing, supply chains, and cumulative exposure

Manufacturing-related GMP violations accounted for a substantial share of warning letters, alongside increases in import alerts and initiatives such as the introduction of a “Green List” to limit exposure to unverified API sources.

Individually, these actions are familiar. Taken together, they point to continued sensitivity around supply chain integrity, especially in globally distributed and efficiency-optimized systems. Oversight in these environments remains heavily dependent on documentation, inspections, and episodic verification, which may struggle to keep pace with scale and complexity.

Clinical research and oversight capacity

Only a small proportion of warning letters were formally attributed to clinical research and IRB violations. On its own, this could be interpreted as a sign of relative stability in this area. At the same time, CDER reported extensive review activity, including assessments of clinical data across numerous applications and investigation of a large number of bioresearch complaints.

Here, the signal may be less about enforcement volume and more about oversight load. Regulatory resources are finite, and increased attention in emerging or high-risk areas inevitably competes with other oversight activities. Clinical research quality therefore cannot be viewed in isolation from broader regulatory system dynamics.

A project perspective on enforcement trends

From a project management standpoint, trends in warning letters are not necessarily an indication of declining standards or worsening behavior. They may also reflect where regulatory systems are adapting to change, particularly in response to new technologies, new business models, and evolving risk profiles.

As operational complexity increases, maintaining alignment between processes, oversight, and regulatory expectations becomes more challenging. Enforcement activity, in this sense, can be read as feedback on where existing frameworks are under the greatest strain.

Looking ahead

CDER’s stated focus on supply chain accountability moving into 2026 suggests awareness of these pressures. Whether industry responses will primarily reinforce existing approaches or lead to more structural adaptation remains to be seen.

An open question is whether new technologies and delivery models inherently require more regulatory attention, and whether this increased attention will stabilize over time as governance frameworks mature — or continue to generate elevated enforcement activity.

For those involved in regulated projects, the underlying lesson remains familiar: quality outcomes depend not only on intent, but on how well systems are designed to evolve alongside the environments they regulate.

References:

FDA official: CDER warning letters up 50% in FY 2025: WASHINGTON – The US Food and Drug Administration's (FDA) Jill Furman, director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance (OC)