FDA Launches AI Tools “Elsa 4.0” and “HALO” to Enhance Review Efficiency

The FDA has launched internal AI tools “Elsa 4.0” and completed integration of over 40 data sources into a new platform called “HALO,” enabling staff to directly query data and automatically generate documents. The agency also initiated a pilot program for AI-based identification of low-risk facilities for “one-day inspection assessments.” Additionally, the FDA’s Oncology Center of Excellence released draft guidance recommending a risk-based streamlined nonclinical study path for biologics and conjugated drugs.