FDA looks to modelling and simulation tools to streamline product reviews

RAPS

28 November 2022 - The US FDA recently published a report on how it uses modelling and simulation, highlighting the untapped opportunities to improve efficiency and predictability at the agency. 

Some of the key opportunities identified in the report are the need to develop guidelines for using such tools in the premarket setting and to harmonise how they are used among its product centres, international regulators and industry.

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Michael Wonder

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Michael Wonder