FDA Use Of Real-World Evidence Relatively Narrow So Far

While the use of real-world evidence to show efficacy by the US FDA is relatively new and infrequent, it tends to be concentrated in applications to treat rare diseases. Within those confines, however, few other trends seem to predominate. The Pink Sheet drew from its own archives as well as FDA review documents, company materials and  clinicaltrials.gov to identify 33 approvals where RWE contributed to the demonstration of efficacy. Below is a breakdown of the kinds of applications those are.

Read More: https://pink.pharmaintelligence.informa.com/PS147020/RWE-By-The-Numbers-Breaking-Down-FDAs-Use-Over-The-Years