After introducing a user fee reauthorization draft in May, the Senate recently added a new proposal that would revamp the Food and Drug Administration’s regulation of clinical tests and diagnostics.

On Wednesday, June 15, the Senate Committee on Health, Education, Labor and Pensions advanced its version of the must-pass Food and Drug Administration (FDA) user fee reauthorization bill. Previously, ...

The Verifying Accurate Leading-edge IVCT Development (VALID) Act has been floating around Capitol Hill for the past four years, but was once again left by the wayside when Congress passed the latest ...

The 2024 election results will have vast consequences for health policy, but one of the less visible effects will be to once again disrupt how the federal government regulates diagnostic tests.

The Verifying Accurate Leading-edge IVCT Development (VALID) Act seems poised for passage in 2022, a bit of welcome relief for those stuck in the regulatory twilight world of the lab-developed test ...

Healthcare issues related to clinical laboratories; H.R. 2377/S. 1000, the Saving Access to Laboratory Services Act (SALSA), provisions relating to reform of Medicare reimbursement for clinical ...

WASHINGTON--(BUSINESS WIRE)--College of American Pathologists (CAP) President Patrick Godbey, MD, FCAP, issued the following regarding the reintroduction of the Verifying Accurate Leading-edge IVCT ...

Laboratory-developed tests (LDTs) constitute a class of diagnostic in vitro tests that are designed, manufactured, and used within a single laboratory. The Food and Drug Administration (FDA) has long ...