FDAsafety guidance66% confidence
Compounding Quality Center of Excellence
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (immunology) as Eli Lilly; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Compounded drugs pose unique risks to patients because they are not reviewed by the agency for safety, effectiveness or quality. The Center of Excellence FDA will explore new ways to engage and collaborate with outsourcing facilities to improve the overall quality of compounded drugs.
Supporting Context
- Therapeutic area
- Dermatology · Atopic Dermatitis
- Sub-indication
- Immunology
Related signal: FDA approves Lilly's EBGLYSS® for atopic dermatitis with unique dosing regimen