{
  "node_id": "us-fda-real-world-evidence-programme-pharma",
  "title": "US FDA Real-World Evidence Programme 2018 - RWE Framework for Drug and Biological Products: Real-World Data Sources, Study Designs, Data Standards, Regulatory Submissions and Programme Guidance",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.1",
  "last_updated": "2026-04-30",
  "bluf": "This regulation outlines the FDA's framework for using real-world data (RWD) and real-world evidence (RWE) to support regulatory decisions for drugs and biological products, including…",
  "paywall": {
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    "_note": "Full crosswalk values included in vault response"
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  "dependencies": [
    "fda-21st-century-cures-act-digital-health-provisions",
    "fda-real-world-evidence-program-guidance-2018",
    "fda-21-cfr-part-314-nda-new-drug-application",
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  "primary_citations_count": 5,
  "workflow_steps_count": 10,
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  "citation_preview": [
    "21st Century Cures Act of 2016 - Authority for FDA to evaluate use of real-world evidence to support approval of new indications for approved drugs",
    "Framework for FDA's Real-World Evidence Program - Guidance issued in 2018 for evaluating RWE to support approval under section 505(c) of the FD&C Act"
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}