WASHINGTON (AP) — Makers of medical tests that have long escaped government oversight will have about four years to show that their new offerings deliver accurate results, under a government rule vigorously opposed by the testing industry. The regulation finalized Monday by the Food and Drug Administration will gradually phase in oversight of new tests developed by laboratories, a multibillion-dollar industry that regulators say poses growing risks to Americans. The goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and many other illnesses are safe, accurate and reliable. “The final rule announced today aims to provide crucial oversight of these tests to help ensure that important health care decisions are made based on test results that patients and health care providers can trust,” said FDA commissioner Robert Califf, in a release. |
Senior Chinese diplomat meets delegation of Brazilian Workers' PartyNation hailed for brokering SaudiKristalina Georgieva to serve second term as IMF managing directorSudanese army says will help evacuate foreign nationalsRetired general Pavel wins Czech presidential electionHarbin to Moscow freight train delivers vehicles to RussiaAmerican democracy in terminal declineChina calls for intensified diplomatic efforts to end Ukraine crisisWorld Insights: WTO members confront U.S. abuse of security exception for protectionist purposeIndian investigating agency to question Delhi chief minister in liquor policy case