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 ...
If your cancer lab test isn’t valid, wrong results could mean you don’t get a drug that could save your life. Or it could mean you take a drug that won’t help you but will bombard you with side ...
Over the past four years, many of us have become accustomed to a swab up the nose to test for COVID-19, using at-home rapid antigen tests or the more accurate clinic-provided PCR tests with a longer ...
FILE - A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020. Makers of thousands of medical tests that have long escaped oversight ...