Agencies like the U.S. Food and Drug Administration and European Medicines Agency are increasingly leveraging RWD to accelerate drug approvals, support label expansions, and enhance safety monitoring.
Regulatory Momentum is Building
FDA: The agency’s Real-World Evidence Program outlines how RWD can support approval of new indications or satisfy post-marketing requirements.
EMA: Actively incorporates RWD in benefit-risk assessments and has launched initiatives like DARWIN EU to enable robust, pan-European real-world evidence generation.
Agencies like the U.S. Food and Drug Administration and European Medicines Agency are increasingly leveraging RWD to accelerate drug approvals, support label expansions, and enhance safety monitoring.
Regulatory Momentum is Building
FDA: The agency’s Real-World Evidence Program outlines how RWD can support approval of new indications or satisfy post-marketing requirements.
EMA: Actively incorporates RWD in benefit-risk assessments and has launched initiatives like DARWIN EU to enable robust, pan-European real-world evidence generation.
