{
  "signal_id": "SIG-2026-021",
  "observed_date": "2026-05-01",
  "category": "AI + Drug Development",
  "title": "FDA reports increasing use of AI across the drug-development lifecycle",
  "what_changed": "FDA states that CDER has seen significant growth in drug application submissions using AI components across nonclinical, clinical, postmarketing, and manufacturing phases.",
  "why_it_matters": "AI is becoming embedded across regulated product development rather than remaining a separate digital-health category.",
  "affected_actors": [
    "FDA CDER",
    "biopharma",
    "AI developers",
    "clinical-research organizations"
  ],
  "decision_implication": "Track where FDA expectations become more explicit by phase and build those requirements into evidence/adoption readiness for AI-enabled life-science products.",
  "status": "Active regulatory trend",
  "evidence_class": "E5 — official FDA source",
  "impact": 4,
  "immediacy": 4,
  "relevance": 5,
  "novelty": 4,
  "adoption_leverage": 4,
  "priority_score": 85,
  "sources": [
    "https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/artificial-intelligence-drug-development"
  ],
  "public_slug": "/signal/2026-05-01-fda-ai-drug-development/",
  "watch_conditions": [
    "Guidance",
    "submission examples",
    "validation expectations",
    "postmarket use."
  ],
  "last_verified": "2026-08-08",
  "version": "1.0"
}