{
  "schema_version": "1.0",
  "id": "M-001",
  "name": "AI in Medicine",
  "slug": "ai-designed-drug-fda-approval-2032",
  "canonical_url": "https://cortist.com/forecast/ai-designed-drug-fda-approval-2032/",
  "question": "Will a verifiably AI-designed novel drug receive FDA approval by the end of 2032?",
  "status": "editorial_candidate",
  "publication_date": "2026-10-23",
  "deadline_utc": "2032-12-31T23:59:59Z",
  "probability": null,
  "has_numerical_forecast": false,
  "independently_locked": false,
  "scoring_eligible": false,
  "scored": false,
  "forecast_owner": "Cortist editorial research",
  "event_definition": "At least one new molecular drug or biologic receives original US FDA marketing authorization through an NDA or BLA by December 31, 2032, and independent documentation shows a material de novo AI contribution to the design of the active therapeutic candidate before laboratory synthesis or lead selection. Clinical trial registration, Fast Track designation, AI-supported diagnostics and merely AI-assisted data analysis do not qualify.",
  "proposed_threshold": "At least one eligible US FDA NDA/BLA approval with independently documented de novo AI molecular design",
  "proposed_yes_criteria": [
    "FDA Drugs@FDA or a corresponding official authorization record establishes original approval for a new therapeutic active ingredient by the deadline.",
    "A dated, independently scrutinizable paper, patent trail and/or third-party audit identifies the candidate's actual AI-generated or AI-directed molecular design contribution.",
    "Two independent reviewers sign off that the qualifying contribution was substantive and occurred before the therapeutic candidate was selected."
  ],
  "proposed_no_criteria": [
    "A complete review of eligible original FDA approvals through December 31, 2032, finds no qualifying candidate with adequate independent provenance.",
    "Where design claims remain undocumented, do not count the product as a positive observation."
  ],
  "unresolved_prelock_requirements": [
    "Define minimum acceptable provenance and the independent review panel before locking.",
    "If a drug is approved but the company cannot disclose enough design history, its qualification is unresolved; do not silently count a corporate press release.",
    "Set a latest adjudication and appeals date; clarify how accelerated FDA approvals and biologics are treated."
  ],
  "limitations": "FDA AI-tool qualification, clinical trial entry or Fast Track designation is NOT a drug marketing approval; AI's design contribution must be independently documented.",
  "sources": [
    {
      "label": "US FDA: Novel drug approvals",
      "url": "https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026",
      "note": "Primary approval listing; approval does not label whether a drug was designed by AI."
    },
    {
      "label": "Nature Reviews Drug Discovery, August 2026",
      "url": "https://www.nature.com/articles/s41573-026-01496-2",
      "note": "Independent critique: molecular-design attribution often lacks public detail and clinical translation remains unproven."
    },
    {
      "label": "FDA: Drug development and review definitions",
      "url": "https://www.fda.gov/drugs/investigational-new-drug-application-ind/drug-development-and-review-definitions",
      "note": "Explains trials, safety and regulatory milestones."
    },
    {
      "label": "AI-enabled drug pipeline review, 2026",
      "url": "https://doi.org/10.1016/j.ctrv.2026.103223",
      "note": "Cross-sectional review reports 129 AI-enabled clinical candidates; most are early-stage and not approvals."
    }
  ]
}