FDAsafety guidance66% confidence
Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Janssen; the same agency is already in play for this signal, so precedent weight is higher.
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 · Antifungal
- Sub-indication
- General
Related signal: FDA Accepts Supplement for SPORANOX (Itraconazole) by Janssen