FDAapproval83% confidence
Understanding the Risks of Compounded Drugs
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable approval decision relevant to Roche.
Regulatory Analysis
Compounded drugs are not FDA-approved. This means the agency does not verify their safety, effectiveness or quality before they are marketed. Learn more.
Supporting Context
- Therapeutic area
- Infectious Diseases · Tuberculosis
- Sub-indication
- General
Related signal: Roche's Elecsys IGRA TB Test Receives CE Mark for Tuberculosis Detection