FDAsafety guidance72% confidence
FDA AP — ONTRUZANT (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to radiation therapy companies.
Regulatory Analysis
Application BLA761100. Sponsor: SAMSUNG BIOEPIS CO LTD. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: TRASTUZUMAB-DTTB.
Supporting Context
- Therapeutic area
- Oncology · Radiation Therapy
- Sub-indication
- General
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