FDAsafety guidance66% confidence
FDA AP — IMULDOSA (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Accord Biopharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application BLA761364. Sponsor: ACCORD BIOPHARMA INC.. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: USTEKINUMAB-SRLF.
Supporting Context
- Therapeutic area
- Immunology · IL-12/23
- Sub-indication
- General
Related signal: FDA Accepts Supplement Application for IMULDOSA by Accord Biopharma