FDAsafety guidance66% confidence
FDA AP — THALOMID (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Bristol-Myers; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA020785. Sponsor: BRISTOL-MYERS. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: THALIDOMIDE.
Supporting Context
- Therapeutic area
- Oncology · Multiple Myeloma
- Sub-indication
- General
Related signal: FDA Approves Supplemental Application for Thalidomide (Thalomid)