Association of expedited review programmes with postmarketing safety events of new drugs approved by the US food and drug administration between 2007 and 2017

In the model which accounted for the time-to-first event, single use of expedited programmes correlated inversely to the chance of safety events (adjusted HR 0.63, 95% CI 0.45 to 0.89; p=0.009), while triple or more use had marginally significant higher risk (adjusted HR 1.58, 95% CI 0.99 to 2.53; p=0.055).

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