FDAsafety guidance66% confidence
FDA AP — IDKIT:HP (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Meridian Bioscience; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA021314. Sponsor: MERIDIAN BIOSCIENCE. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: CITRIC ACID, UREA C-13.
Supporting Context
- Therapeutic area
- Diagnostics · Biomarkers
- Sub-indication
- General
Related signal: FDA Approval Update for Meridian Bioscience's NDA021314