FDAsafety guidance72% 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: sets a safety guidance precedent in the same sub-indication (asthma) as AstraZeneca.
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
- Respiratory · Asthma
- Sub-indication
- Asthma
Related signal: EVOLVE Study to Assess Real-World Effectiveness of Tezepelumab in Severe Asthma in Greece