FDA Unveils Technology Modernization Plan To Better Handle ‘Tsunami’ Of Incoming RWE Data
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.
You may also be interested in...
After launching its Data Modernization Action Plan (DMAP) one year ago, and its Technology Modernization Action Plan (TMAP) three years ago, the US Food and Drug Administration has provided an update to its progress with “Modernization in Action.”
Agency heads say the new plan will siphon and aggregate more data that could help the regulatory body make better and faster regulatory decisions.
Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.