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Indica Labs Receives FDA Clearance for HALO AP Dx Digital Pathology Platform for Use with Hamamatsu...
WRBL Columbus· 2 hours agoFood and Drug Administration (FDA) has issued a 510(k) clearance to Indica Labs for HALO AP Dx, an enterprise digital pathology platform. HALO AP Dx is indicated for primary ...
It’s Official: Tara Flour Is an Unapproved Food Additive, According to the FDA
Eating Well via Yahoo News· 17 hours agoTara flour made headlines in 2022 after hundreds got sick from Daily Harvest crumbles. Now the FDA...
FDA Roundup: May 21, 2024
FOX 4 Kansas City· 17 hours agoOn Monday, the FDA announced a public workshop, Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products. The purpose of ...
'Ozempic breasts' to 'Ozempic face': What you need to know about weight loss drug side effects
Euronews via Yahoo News· 3 days agoWhile more and more people have been using Ozempic for weight loss purposes, McGowan pointed out...
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 1 day 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 ...
FDA said it never inspected dental lab that made controversial AGGA device
Medical Xpress· 6 days agoThe FDA never inspected Johns Dental Laboratories during more than a decade in which it made the...
FDA Issues Draft Guidance on Informed Consent for Sponsors, Investigators and Institutional Review...
JD Supra· 6 days agoThe U.S. Food and Drug Administration (FDA) recently issued a draft guidance document entitled, Key Information and Facilitating Understanding in Informed Consent. The draft ...
BSI launches new regulatory standard team for software and AI
Medical Device Network via Yahoo Finance· 2 hours agoAt the same time, the UK-based AI company, Brainomix, has seen its 360 e-Lung system granted market...
The FDA's New Pre-Harvest Agricultural Water Rule: Impacts on PFAS-Contaminated Groundwater? | JD...
JD Supra· 5 days agoWith certain exceptions for growers of Covered Produce, the FDA's new rule requires pre-harvest agricultural water assessments for hazard identification and risk management ...
FDA Withdraws Approval of FGFR Inhibitor for Bile Duct Cancer
MedPage Today· 2 days agoThe FDA has withdrawn the approval of infigratinib (Truseltiq) as a second-line treatment for...
