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PDUFA and its reauthorizations have expanded the variety and mother nature of drug critique paths. As Section of the settlement with sector that triggered PDUFA I passage, FDA fully commited (outside of the legislation’s textual content alone) to codifying the Priority Overview procedure – for medicines that address a serious problem and supply “significant improvement in basic safety or success” – and to the goal evaluate time of 6 months for precedence assessment medications (at the time, the target for traditional overview was twelve months).

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