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 sleep disorder market.
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
- Sleep Disorders · Herbal Medicine
- Sub-indication
- General
Related signal: Real-World Study on Dong'e Brand Ejiao Yuanjiang for Sleep Improvement