image credit: Pixabay

FDA to Rely on Real World Data and Evidence for Future Research and Market Approvals

October 1, 2021


Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional sources of information into the research and approval processes, notably data provided by patient registries and medical records able to inform traditional clinical trials. FDA and the European Medicines Agency (EMA) are looking to tap real-world data (RWD) and real-world evidence (RWE) more broadly to accelerate the research and market approval process.

Read More on Biopharm International