FDAsafety guidance83% confidence
Real-World Evidence Submissions to the Center for Biologics Evaluation and Research & the Center for Drug Evaluation and Research
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to KSHB Biopharma.
Regulatory Analysis
As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
Supporting Context
- Therapeutic area
- Rheumatology · Biologic
- Sub-indication
- General
Related signal: KSHB002 Trial Shows Equivalence to ORENCIA in PK, Safety, and Immunogenicity for RA