FDAsafety guidance66% confidence
Compounding Quality Center of Excellence | Self-Guided Online Trainings
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (immunology) as AbbVie; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
FDA Compounding Quality Center of Excellence’s is providing anytime, anywhere training resources to support outsourcing facilities and other stakeholders in their efforts to enhance the quality of compounded drugs.
Supporting Context
- Therapeutic area
- Dermatology · Autoimmune Disease
- Sub-indication
- Immunology
Related signal: FDA Lists Quinacrine Hydrochloride for Compounding in Cutaneous Lupus Erythematosus