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FDA, doctors warn about compounded Ozempic. What we found at metro weight loss clinics
WFTV via Yahoo News· 10 hours agoIt’s a popular drug that millions of people are taking to lose weight, but the federal government...
...OrthoFX™ Announces Nationwide Availability Of The First and Only FDA Cleared Aligners Designed...
NBC 17 Raleigh· 31 minutes agoNiTime is the first and only clear aligner system explicitly designed for shorter wear time and cleared by the U.S Food and Drug Administration (FDA) 510(k), and is now available ...
FDA Finally Moves to Scrutinize Specialized Health Screenings
ProPublica· 4 hours ago“This is a significant step forward,” said Peter Lurie, president and executive director of the...
FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
The National Law Review· 12 hours agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and...
FDA Dataset Helps Firms Scrutinize Third-Party Chemistry Labs | JD Supra
JD Supra· 1 day agoMedical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties. The Food and Drug Administration ...
It’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs)...
The National Law Review· 16 hours agoToday, on April 29, 2024, following more than a decade of discourse, the U.S. Food and Drug...
FDA Roundup: April 30, 2024
WFRV 5 Green Bay· 14 hours agoToday the FDA, in coordination with the U.S. Department of Justice (DOJ), announced that the U.S. Marshals Service seized unauthorized e-cigarette products valued at more ...
FDA approves INGREZZA SPRINKLE for swallowing difficulties By Investing.com
Investing.com· 12 hours agoNeurocrine (NASDAQ:NBIX) Biosciences, Inc. (NASDAQ:NBIX) today announced that the U.S. Food and Drug...
FDA finalizes rule to increase oversight of lab tests
Boston Herald· 15 hours agoThe rule effectively reclassifies tests developed and performed in a lab as medical devices for the...
FDA approves Labcorp companion diagnostic for Pfizer gene therapy
Medical Device Network via Yahoo Finance· 22 hours agoThe US Food and Drug Administration (FDA) has approved Labcorp’s nAbCyte Anti-AAVRh74var HB-FE assay...