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Magellan Diagnostics of Billerica agrees to pay $42 million to resolve criminal charges in lead test...
The Boston Globe· 58 minutes agoThe problems at Magellan first became public in 2017 when the FDA warned that the company was having...
US FDA staff says Guardant's test may fail to detect some pre-cancerous tumors
Reuters via Yahoo News· 13 hours agoThe reviewers, however, said the test may increase compliance with screening for colorectal cancer...
It’s Official: Tara Flour Is an Unapproved Food Additive, According to the FDA
Eating Well via Yahoo News· 7 hours agoTara flour made headlines in 2022 after hundreds got sick from Daily Harvest crumbles. Now the FDA...
FDA seeks AI tech to predict, detect Parkinson’s symptoms
MedTech Dive via Yahoo Finance· 16 hours agoBy testing artificial intelligence and machine learning models, the agency hopes to come up with...
Small Business - Cordele Dispatch | Cordele Dispatch
Cordele Dispatch· 6 hours agoFDA Roundup: May 21, 2024 PR Newswire SILVER SPRING, Md., May 21, 2024 SILVER SPRING, Md., May 21, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing ...
What's Going On With Colorectal Cancer Diagnostic-Focused Guardant Health Stock On Tuesday?
Benzinga via Yahoo Finance· 6 hours agoTuesday, the FDA's staff reviewers raised concerns regarding Guardant Health Inc's (NASDAQ:GH)...
FDA sets new review date for Halozyme's drug delivery tech By Investing.com
Investing.com· 10 hours agoHalozyme (NASDAQ:HALO) Therapeutics, Inc. (NASDAQ: HALO) announced that the U.S. Food and Drug...
LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements | JD Supra
JD Supra· 20 hours agoOn May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed ...
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 20 hours agoOn May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration ...
Hims & Hers Is Now Selling Semaglutide: Here's What You Should Know
Verywell Health via Yahoo Finance· 2 hours agoCompounded drugs are not approved by the Food and Drug Administration (FDA), and do not require...
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