FDAsafety guidance72% confidence
Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as gene therapy products.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Gene Therapy · Rare Diseases
- Sub-indication
- Ild
Related signal: Long-Term Safety Follow-Up for Seattle Children's Gene Therapy Products Initiated