Pharmaceutical Executive January 18, 2022
Since 2016, the 21st Century Cures Act has required the Food and Drug Administration (FDA) to consider the utility of any real-world evidence (RWE) study submitted by a sponsor in support of an efficacy claim for a medical product. However, even as the FDA is beginning to accept more submissions with RWE, many manufacturers still face uncertainty and roadblocks preventing optimal utilization.
A major reason for this confusion stems from how the FDA has accepted the use of real-world data (RWD) for drug safety issues. Since before Bitcoin, the iPhone, and hybrid cars, pharmacoepidemiologists have been using RWD obtained from large databases of electronic healthcare records (EHR), and other observational data sources, to describe associations between medical products and potential...
Today's Sponsors
Today's Sponsor