FDA Unveils Technology Modernization Plan To Better Handle ‘Tsunami’ Of Incoming RWE Data

19 Sep 2019

• By Sue Darcey

The US agency has introduced a new action plan geared toward handling an expected incoming storm of real world evidence (RWE) data that companies will be submitting to support future device and drug approvals.

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The US Food and Drug Administration unveiled a new Technology Modernization Action Plan (TMAP) on 18 September to close a gap between new scientific advances in data gathering and regulatory technology needed to protect public health. The plan describes actions that the agency will take over the next three years to modernize its use of technology for the capture of real world evidence (RWE) data, and other purposes.

TMAP includes three major elements: modernizing the FDA’s technology infrastructure, enhancing the agency’s abilities to develop technology products to support...