The FDA has finalized its regulatory rule that aims to bring laboratory-developed tests more in-line with how the agency oversees other diagnostics. At its heart, the 528-page final rule (PDF) looks ...
ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The Food and Drug Administration issued a rule on Monday that ...
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 ...
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 ...
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