FDAsafety guidance72% confidence
S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ophthalmology) as Kiora Pharmaceuticals.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Ophthalmology · Retinitis Pigmentosa
- Sub-indication
- Ophthalmology
Related signal: Kiora Pharmaceuticals initiates Phase II trial of KIO-301 for late-stage Retinitis Pigmentosa