Posted by Michael Wonder on 02 Oct 2021
FDA, sponsors advance reliance on real world data & evidence
2 October 2021 - Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional sources of information into research and approval processes, notably data provided by patient registries and medical records able to inform traditional clinical trials.
The FDA and the EMA are looking to tap real world data and real world evidence more broadly to accelerate the research and market approval process.
