Industry News and Headlines

Navigating the FDA After the Storm To Advance Drug Candidates

After a wave of senior departures and a 3,500‑position cut, the FDA entered 2026 with a largely inexperienced workforce, raising uncertainty for drug developers. The agency’s new AI guidance, released in January, outlines best practices but emphasizes human oversight and bias mitigation. Sponsors are urged to seek early clarification and leverage AI responsibly to keep review timelines on track. Success will hinge on clear communication with the FDA and robust data packages despite the agency’s staffing challenges.