CDER Compliance Chief Details Compliance Shifts

CDER Office of Compliance director Jill Furman outlined a year of sweeping operational shifts, heightened enforcement, and emerging use of artificial intelligence during remarks at the Food and Drug Law Institute’s annual enforcement conference in Washington, DC, 12/4. She described the Center’s compliance program navigating two simultaneous waves of upheaval: CDER’s consolidation of field compliance functions following the 10/2024 reorganization of the Office of Regulatory Affairs (now the Office of Inspections and Investigations)  and a set of broader, less anticipated agency-wide changes in 2025, presumably staff reductions and departures.

Despite turbulent transitions, Furman said CDER’s compliance program “maintained an unwavering focus on our mission” while becoming more nimble and innovative. “Our Office of Compliance has had real agility in responding to both of these changes… actually evolving our operations and adapting to the change that we were experiencing,” she said.

Furman noted that the unification of human drug compliance functions into CDER has sharply reduced duplicate reviews and created a “single, coherent strategic vision” for enforcement. CDER’s Office of Compliance now issues all human drug warning letters, recommends enforcement actions, tracks consent decrees, and classifies inspections.

The streamlined structure has produced striking gains, she said, including CDER issuing 881 inspection classification letters in FY 2025, nearly tripling the 260 letters issued the prior year. The shift also centralized communications with companies under investigation, providing one point of contact and a fully integrated team of case officers.

Overall, Furman told FDLI that Warning Letters climbed by about 50% in FY 2025. While Current Good Manufacturing Practice violations remained the largest category — cited in 42% of letters — one of the biggest new drivers was action against telehealth platforms selling unapproved compounded drugs with “false and misleading claims.” That category alone accounted for 22% of this year’s warning letters. The agency also saw “a significant increase” in actions against illegal internet pharmacies.

To intercept unsafe or poor-quality drug products, CDER added 126 firms to the agency’s import alert lists this year, permitting automatic detention of their products, Furman said. The office also oversaw 317 drug recall classifications covering more than 677 products.

Furman also highlighted the work of the Office of Scientific Investigations, which oversees clinical trial conduct and data integrity. In FY 2025, the office reviewed clinical data for 150+ NDA/BLA applications, evaluated 900+ complaints about clinical trials, and issued 21 Official Action Indicated letters recommending regulatory or administrative actions. Violations included failure to submit IND applications and serious protocol issues. CDER also expanded its ClinicalTrials.gov compliance push, issuing 50 pre-notice letters but only needing three formal notices after sponsors corrected deficiencies.

Furman also acknowledged intense interest in the FDA’s approach to artificial intelligence (AI), and the prioritization from the Office of Commissioner of AI adoption. CDER is exploring new AI tools that “augment our capabilities,” she said, emphasizing: “There is no replacement of our human work with AI.”

Looking ahead to 2026, Furman said that CDER will continue to prioritize risk-based enforcement — particularly products tied to injury reports, vulnerable populations, or substantive quality failures. Supply chain accountability across distributors and intermediaries will also remain a key focus.