Real-World Evidence Usage in Regulatory Approvals from USFDA and EMA

Shaikh J, Samnaliev M

Real-world evidence (RWE) studies can be used at all stages of the product lifecycle and can provide information that complements randomized controlled trials (RCTs) to support clinical, regulatory, and reimbursement decisions. RWE is becoming a part of integrated evidence generation and creating continuity from premarket to iterative post-market approval decisions. The acceptance of RWE for regulatory approval differs across countries. This study identifies and compares the inclusion of RWE as part of an evidence package to support approvals by the United States Food and Drug Administration (USFDA) & European Medicines Agency (EMA).

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