How long should a therapy take to journey from lab bench to bedside? The obvious need to prove the safety and efficacy of an investigational therapeutic product has notoriously led to delays that that can be aggravating for both drug developers and patients. The time taken between general acceptance of a new drug and its official approval, the 'drug lag', has been particularly pronounced in Japan, where drugs approved elsewhere in the world must undergo additional regulatory review, often requiring clinical trials performed in Japanese patients to supplement safety and efficacy data that are deemed sufficient for approval in the United States or by countries in Europe.
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