A Senate proposal to overhaul the way the FDA regulates diagnostics is raising questions over whether the agency has the resources it needs to undertake such a project.
The inclusion of the VALID Act (H.R. 4128) in the Senate’s must-pass draft user fee package marks a critical step in realizing changes nearly a decade in the making over how much oversight the Food and Drug Administration should exert over diagnostic tests, particularly those created in a single laboratory.
But the bill leaves a lot of text in brackets, indicating there are still major sections that have been proposed ...