FDAsafety guidance66% confidence
Compounding Quality Center of Excellence
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Azurity Pharmaceuticals; 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
- Pharmaceuticals · Compounding
- Sub-indication
- General
Related signal: FDA Orders Azurity Pharmaceuticals to Halt Distribution of Unapproved Compounding Kits