11 February 2026 • 1 minute read
FDA in focus
2025 review and 2026 outlookAmid a year of significant organizational transformation, including a major reduction in force and sweeping shifts in leadership and regulatory philosophy, Food and Drug Administration (FDA) activity in 2025 reshaped long standing norms across the industries it oversees.
This year’s FDA in focus, an annual report from DLA Piper’s FDA Regulatory practice, analyzes how these changes influenced policy and regulatory expectations for drugs and biologics, combination products, medical devices, digital health technologies, food and dietary supplements, clinical trials, the advertising and promotion of medical products, and more.
Our report also outlines what stakeholders may anticipate in 2026, drawing from FDA’s evolving priorities, its fiscal year 2026 budget, and emerging trends in rulemaking and enforcement, among others.
Report: FDA in focus
In 2025, FDA concentrated on rebuilding and modernizing its internal infrastructure amid unprecedented organizational and leadership changes. Against the backdrop of a significant reduction in force, shifting regulatory philosophies, and evolving policy priorities, the Agency focused on strengthening food safety, advancing medical product innovation, and enhancing oversight across its programs.
