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Fast-track FDA drug approvals and safety warnings

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To ensure that patients have more timely access to new and innovative medicines, regulatory bodies such as the European Medicines Agency (EMA) and the USA Food and Drug Administration (FDA), have developed a range of accelerated approval pathways.1 For such abbreviated development processes, drugs may be approved after a single phase II trial or using surrogate measures rather than actual clinical outcomes.1,2 In general, trials of drugs that have been through accelerated approval pathways involve relatively small numbers of patients and less …

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