FDA outlines plans for $400M budget boost

FDA Commissioner Scott Gottlieb Tuesday released a statement outlining how the agency plans to spend the roughly $400 million FY19 budget increase the Trump administration has requested.

The funds would be used to develop regulatory standards that are needed to advance continuous manufacturing of small molecule and biologic drugs, Gottlieb said. They would also be deployed to facilitating the use of real-world evidence, in both premarket and postmarket settings. ...