FDAsafety guidance83% confidence
Phase 1 IND Learning Resources
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Hangzhou Zhongmei Huadong Pharmaceutical.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Dermatology · Psoriasis
- Sub-indication
- General
Related signal: Phase III Trial of MC2-01 Cream for Plaque Psoriasis Shows Efficacy and Safety