Drug Labeling Volatility Index →

{
  "product_id": "ADW-357",
  "entity": "US-Drug-Labeling",
  "score": 54,
  "trend": "rising",
  "confidence": 0.67,
  "top_drivers": [
    {
      "factor": "rolling_12mo_labels",
      "contribution": 50161
    },
    {
      "factor": "prior_12mo_labels_baseline",
      "contribution": 42257
    },
    {
      "factor": "velocity_ratio",
      "contribution": 1.187
    },
    {
      "factor": "recent_3mo_labels",
      "contribution": 10891
    },
    {
      "factor": "yoy_3mo_pct_vs_prior_quarterly_avg",
      "contribution": 3.1
    }
  ],
  "recommended_use": "Track the velocity of FDA drug label updates as a proxy for regulatory activity, post-market safety signal intensity, and drug-lifecycle churn. Rising scores indicate accelerating labeling changes — useful for pharmacovigilance monitoring, formulary-update workload forecasting, and health-IT data-refresh planning. Descriptive only — not a drug-safety or recall signal.",
  "methodology_version": "ADW-357-live-1.0",
  "freshness": "2026-06-27T00:00:16.667Z",
  "coverage": "All prescription and OTC drug labels in the openFDA drug label database. Covers initial approvals, supplemental updates, and reformulation labeling events. US scope (FDA-approved products). Global manufacturers included.",
  "source_lineage": [
    "api.fda.gov/drug/label.json?search=effective_time:[trailing-12mo] (keyless)",
    "api.fda.gov/drug/label.json?search=effective_time:[prior-12mo] (keyless)",
    "api.fda.gov/drug/label.json?search=effective_time:[trailing-3mo] (keyless)"
  ],
  "allowed_use": "informational",
  "validation_status": "descriptive",
  "rolling_12mo_labels": 50161,
  "prior_12mo_labels": 42257,
  "velocity_ratio": 1.187,
  "neutral_ratio": 1.1,
  "recent_3mo_labels": 10891,
  "next_fresh_at": "2026-07-27T00:00:16.667Z",
  "data_notes": [
    "effective_time is manufacturer-reported and may lag FDA approval date by days to weeks.",
    "Count includes initial NDA/ANDA approvals + supplemental label changes (no breakdown available).",
    "New-drug-approval cohorts can inflate YoY ratio in high-approval years (e.g. 2024-2025 surge).",
    "Score baseline 50 calibrated to NEUTRAL_RATIO=1.10 (10% annual labeling growth).",
    "Score 54.1 observed at 2026-06-25 baseline (ratio=1.189, rolling 50,257 vs 42,262)."
  ]
}