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Nobody keeps track of how differently the same drug is approved and dosed around the world. A public scoreboard would make the differences visible and push regulators to converge.
For the same oncology drug, the approved indications, biomarker requirements, dosing and line of therapy can differ between FDA, EMA, PMDA, NMPA and others, and the reasons are rarely documented. The proposal is an open, machine-readable dataset that parses approved labels for every oncology drug across at least ten regulators, scores divergence per indication, and publishes the reasons where regulators have stated them. Regulators and sponsors would receive an annual divergence report.
Shares Knowledge reaches practice too slowly, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Knowledge reaches practice too slowly.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Knowledge reaches practice too slowly.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Knowledge reaches practice too slowly.