Bloomberg Law
May 27, 2022, 9:30 AM

Diagnostics Revamp Inches Forward in Senate’s FDA User Fee Plan

Jeannie Baumann
Jeannie Baumann

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 ...

Learn more about Bloomberg Law or Log In to keep reading:

Learn About Bloomberg Law

AI-powered legal analytics, workflow tools and premium legal & business news.

Already a subscriber?

Log in to keep reading or access research tools.