Original article excerpt
Server-side extracted preview paragraphs from the original source.
Real-world evidence is now a regulatory and payer expectation. See how Databricks Genie helps medical affairs teams query RWE data conversationally.
Real-World Evidence (RWE) has moved from a regulatory novelty to an expectation. Payers increasingly require RWE to support formulary placement. Regulators are accepting RWE for label expansions and post-approval commitments as part of the FDA's Real-World Evidence Framework, established under the 21st Century Cures Act. Physicians want outcome data from patients like their own. The appetite for evidence generated outside the controlled trial environment has never been higher.