Article Reflects on FDA’s Moves in Last Decade

A recent article by The Pink Sheet takes a step back to highlight how the Food and Drug Administration (FDA) has changed its policies on a number of issues, including opioids and the use of real-world evidence.

“[The] FDA has used real-world evidence – the data about the usage and potential benefits or risks of a drug that are derived from sources other than traditional clinical trials – to evaluate the postmarket safety of products, and in some instances has accepted RWE to support drug development approvals,” the article states. “But the agency is going further under the framework, establishing demonstration projects and increasing engagement with stakeholders.”

To read the full report, click here.