FDAsafety guidance83% confidence
Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Eli Lilly.
Regulatory Analysis
As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. Learn more.
Supporting Context
- Therapeutic area
- Infectious Disease · Viral and Bacterial Pathogens
- Sub-indication
- General
Related signal: Lilly expands infectious disease portfolio with three strategic acquisitions