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Drugs given accelerated or conditional approval on surrogate endpoints have often stayed on the market for years after the confirmatory trial stalled or failed. The approval would lapse automatically if the sponsor missed agreed enrolment milestones or the readout date, unless an independent panel granted a documented extension.
Accelerated and conditional approvals have often stayed on the market for years after confirmatory trials stalled or failed (the 'dangling' approvals reviewed in 2021). The FDORA 2022 reforms gave FDA power to require confirmatory trials to be underway and to expedite withdrawal; the EU renews conditional authorisations annually. The proposal is a self-executing sunset: at approval, the sponsor agrees enrolment milestones and a readout date, and the authorisation lapses without further procedure if the milestones are missed, unless an independent panel grants a documented extension.
Shares Accelerated approval, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Incentives reward me-too drugs and marginal gains, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, 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, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Accelerated approval, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on.
Shares Accelerated approval, Regulatory divergence between regions.