Bloomberg Law
June 26, 2019, 5:36 PM

Modernizing Clinical Trials Leaves FDA ‘a Large Load of Work’

Jeannie Baumann
Jeannie Baumann

Innovative, targeted treatments will reach patients more quickly with the FDA’s overhaul of the costly, lengthy clinical trials system—but it’s going to take a while, the agency’s No. 2 said.

The Food and Drug Administration has been setting up a number of frameworks mandated through the 21st Century Cures Act, the sweeping biomedical law from 2016 (Pub. L. 114-255). One that came out last year, for instance, discusses how to harness patient-generated data such as electronic health records. But those frameworks are short-term goals that ultimately aim to modernize the infrastructure for conducting clinical trials, Amy P. ...