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. |
Airbnb shares slide on lower revenue forecast despite a doubling of net incomeMicah Leon's sevenLawyers' coalition provides new messengers for Black voter engagementHow Kim Kardashian's breathtaking silver corset proves the dangerous centuriesIppei Mizuhara, exWoman seeks to drop sexual assault lawsuit against exShopify's shares tumble on weak outlook after a very strong start to 2024Cowboys cut Martavis Bryant and end the receiver's latest comeback attemptHow a computer whiz duped the world into believing Katy Perry attended the 2024 Met GalaIowa facility that mistreated residents with intellectual disabilities nears closure