Search results
FDA Issues Final Rule on Regulation of Laboratory Developed Tests | JD Supra
JD Supra· 12 hours agoOn April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs). This final ruling amends the FDA</ ...
FDA finalizes rule to increase oversight of lab tests
Boston Herald· 28 minutes agoThe rule effectively reclassifies tests developed and performed in a lab as medical devices for the purposes of FDA regulation. It’s a controversial strategy, but in the wake ...
Biotech Stocks Facing FDA Decision In May 2024
RTT News· 1 hour agoAs April comes to an end, attention shifts to biotech stocks poised for regulatory events in May. The FDA approved eight novel drugs last May, contributing to a total of 55 ...
FDA issues final rule regulating LDTs as medical devices
Medical Device Network via Yahoo Finance· 10 hours agoThe FDA ruling follows years of industry back and forth and sees the government body choosing to...
FDA approves Labcorp companion diagnostic for Pfizer gene therapy
Medical Device Network via Yahoo Finance· 7 hours agoThe US Food and Drug Administration (FDA) has approved Labcorp’s nAbCyte Anti-AAVRh74var HB-FE assay...
FDA finalizes lab test regulations with more flexibility
Politico· 3 hours agoThe new requirements, which kick in over the next four years, include a handful of substantial changes from the agency’s initial proposal. Chief among them is a grandfathering clause which means ...
FDA defends LDT final rule, while critics fear it upends lab industry
MedTech Dive via Yahoo Finance· 8 hours agoThe new policy aims to ensure important diagnostics remain available to patients, but some experts...
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
Associated Press via Yahoo News· 1 day agoThe regulation finalized Monday by the Food and Drug Administration will gradually phase in...
Pfizer and Genmab’s Tivdak wins full FDA approval for cervical cancer
Pharmaceutical Technology via Yahoo Finance· 5 hours agoPfizer and Genmab’s Tivdak (tisotumab vedotin-tftv) has won full approval from the US Food and Drug...
Bird flu: Why FDA says milk safe despite 1 in 5 positive tests for virus
Newsweek· 1 day agoThe Food and Drug Administration (FDA) said last week that 1 in 5 retail milk samples across the...
