{
  "node_id": "us-pdufa-prescription-drug-user-fee-act",
  "title": "Prescription Drug User Fee Amendments",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.1",
  "last_updated": "2026-04-30",
  "bluf": "The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect user fees from persons submitting certain human drug applications for review or named as sponsors in approved applications…",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "nist_framework",
      "iso_standard",
      "industry_mapping",
      "ai_overlay_2026"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "fda-21-cfr-part-314-nda-new-drug-application",
    "fda-21-cfr-part-600-601-biologics-licensing",
    "fda-pdufa-vii-goals-letter-2022"
  ],
  "primary_citations_count": 5,
  "workflow_steps_count": 10,
  "schema_fields_count": 10,
  "citation_preview": [
    "Prescription Drug User Fee Amendments - Application Fees: A human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval is assessed a full application fee.",
    "Prescription Drug User Fee Amendments - Application Fees: A human drug application for which clinical data with respect to safety or effectiveness are not required for approval is assessed one-half of a full fee."
  ]
}