FDAsafety guidance83% confidence
Real-World Evidence Submissions to 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 pridopidine.
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.
Supporting Context
- Therapeutic area
- Neurology · ALS
- Sub-indication
- General
Related signal: Pridopidine Phase 3 Trial Initiated for ALS Efficacy and Safety Evaluation
Source
FDA document
View source