Key Compliance Signals from the 2025 FDLI Enforcement, Litigation & Compliance Conference

TL: DR

1. AI is reshaping compliance: both industry and the FDA are accelerating adoption, making a validated, risk-managed use of AI essential.

2. Enforcement is tightening for 2026: With heightened scrutiny across drugs, devices, and a strong focus on systemic, lifecycle-wide risk management.

3. Proactive, predictive compliance is gaining momentum: Unified regulatory intelligence helps organisations prevent surprises, reduce costs, and turn regulatory complexity into strategic advantage.

Introduction

As 2025 draws to a close, the FDLI Enforcement, Litigation & Compliance Conference delivered several clear messages for Quality, Regulatory Affairs, and Compliance leaders. Across sessions, from AI in regulated products to strategic enforcement priorities from FDA CDER, CBER, and OPEQ directors, one theme dominated: regulatory risk is becoming more complex, more interconnected, and more data-driven.

For organisations struggling with fragmented regulatory intelligence and rising compliance workloads, the below takeaways point to an urgent need for predictive, unified approaches to compliance.

1. AI Is Transformative, But Not a Free Pass

The first sessions made it clear: FDA does not view AI as a regulatory exception. Manufacturers remain responsible for safety, effectiveness, and truthful promotion regardless of AI involvement. 

At the same time, both industry and FDA are accelerating AI adoption, from drafting QMS documentation and triaging complaints, to the FDA’s own internal use of tools such as PREDICT and ELSA initiatives.

What this means for compliance leaders: AI can radically improve efficiency, but only if risk management, transparency, and human oversight remain central. This reinforces the need for validated, explainable AI tools, not consumer-grade automation or unchecked LLM outputs.

2. 2026 Will Be a Landmark Enforcement Year

The FDA Center Directors' opinions signalled significant shifts:

• CBER focuses on direct-to-consumer advertising claims compliance and a risk-based inspection schedule pursuant to Section 510(h) of the FD&C Act. 

• CDER is intensifying action on GLP-1 counterfeiting, telehealth advertising compliance, clinical trial misconduct (incident non-reportings), and high-risk imports.

• OPEQ and CDRH highlighted systemic trends in companies’ weaknesses in CAPAs, complaints handling, and MDR reporting, and emphasised the 2026 implementation of the QMSR, fully integrating ISO 13485-style risk management.

What this means for global RA and QA teams: The bar is rising, and enforcement is becoming more holistic, looking at the Total Product Lifecycle and cross-facility systemic patterns rather than isolated findings. This directly supports teams that need sharper insight into competitor activity, evolving inspection trends, and global regulatory changes that often create unexpected compliance risks.

3. Organisations Must Shift from Reactive to Predictive Compliance

Speakers across sessions reinforced that fragmented data, inconsistent processes, and slow internal communication are increasing compliance exposure. Presenting examples including: 

• Medical Device design flaws and weaknesses in risk management leading to MDRs, recalls, and approval refusals.

• Non-reporting or non-timely reporting of MDRs and complaints continues to be the most cited observations during inspections for both US-domestic and foreign companies.

• For Medical Devices: CAPA, complaints, and MDR observations account for 50% of all observations made in 2025. Over 80% of recalls were related to class II MDs.

This is precisely where the GxP AI Insights Platform is positioned to help by enabling:

• Predictive Compliance: Surfacing emerging risks before they become findings or recalls.

• Faster Time to Market: Unifying regulatory intelligence across teams to accelerate submissions and decision-making.

• Reduced Compliance Costs: Eliminating manual tracking and consultant-heavy models through AI-driven automation. 

For both consultants and internal compliance teams, the result is deeper insight delivered faster, and the ability to transform regulatory complexity into actionable operational value.

Looking Ahead

The 2025 FDLI Conference underscored a simple truth: regulatory compliance is no longer an essential safeguard; predictive compliance is becoming a competitive differentiator.

As enforcement intensifies and AI adoption accelerates, healthcare organisations need real-time, predictive insight to stay ahead of global trends. GxP Group will continue translating regulatory complexity into actionable intelligence, enabling safer, faster, and more cost-effective delivery of life-saving therapies.