Devices Guidances
This page lists Medical Device Guidance documents.
Day: June 9, 2025
Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence
As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a …
Real-World Evidence
Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, pl…
Real-World Evidence Submissions to the Center for Biologics Evaluation and Research & the Center for Drug Evaluation and Research
As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on s…
Hiring Veterans: Jobs of the week for June 9, 2025
This post contains jobs for the week of June 9, 2025. Each week, we post relevant and timely listings as we receive them, and for the locations listed…