The Food and Drug Administration could roll out a new logo as soon as this year for companies to stamp on the packaging of "healthy" foods they make, aimed at clearing up confusion on what ...

The Food and Drug Administration on Monday finalized a rule to regulate most tests developed in a lab, in a move that observers expect will face legal challenges and prompt intervention from Congress.

On Friday, Sept. 29, 2023, the FDA laid out a proposal to begin regulating laboratory medical tests, a multibillion-dollar industry that it says poses a growing risk to patients because of ...

The US Food and Drug Administration is proposing to step up its oversight of a growing category of medical tests called laboratory-developed tests. The FDA approves and clears many types of lab ...

The regulation finalized Monday, April 29, 2024 brings tests developed by laboratories under control of the FDA, which has warned that the multibillion-dollar industry poses growing risks to patients.

Under the new proposal, FDA would gradually phase in tighter regulation of lab tests over five years. The agency is considering exempting some existing tests already on the market from review but ...