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JD Supra: CMS Proposes Important Enhancements to the New Technology Add-on Payment Program in the FY...
JD Supra· 15 hours agoProposals include increasing the number of manufacturers eligible for a full three years of NTAP, determining those applicants in a “hold status” with the FDA will no longer ...
FDA Withdraws Approval of FGFR Inhibitor for Bile Duct Cancer
MedPage Today· 6 days agoThe FDA has withdrawn the approval of infigratinib (Truseltiq) as a second-line treatment for...
It’s Official: Tara Flour Is an Unapproved Food Additive, According to the FDA
Eating Well via Yahoo News· 5 days agoTara flour made headlines in 2022 after hundreds got sick from Daily Harvest crumbles. Now the FDA...
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 5 days 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 Roundup: May 21, 2024
FOX 4 Kansas City· 5 days agoOn Monday, the FDA announced a public workshop, Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products. The purpose of ...
Jessica Simpson, Khloe Kardashian & More Who've Weighed In on Ozempic
E! News via Yahoo News· 1 day agoOh, oh, oh, it seems that everyone in Holllywood—including Jessica Simpson, Raven-Symoné, Sophie...
FDA Clarifies Distinction Between Device Remanufacturing and Servicing in Final Guidance | JD Supra
JD Supra· 4 days agoThe FDA issued its final guidance document on Remanufacturing of Medical Devices (Final Guidance) on May 10, 2024 to provide clarification on the difference between device ...
FDA approves belimumab autoinjector for pediatric systemic lupus erythematosus
Medical Xpress· 3 days agoThe U.S. Food and Drug Administration has approved GlaxoSmithKline's 200-mg subcutaneous route of...
Guardant Health Colon Cancer Screening Test Backed by Majority Amidst Robust Debate in FDA Meeting
GenomeWeb News· 2 days agoDuring the event, which highlighted the conclusions of an FDA-commissioned group tasked with evaluating Guardant Shield, a majority of panel members voted to recognize the ...
Indica Labs Receives FDA Clearance for HALO AP Dx Digital Pathology Platform for Use with Hamamatsu...
WRBL Columbus· 4 days 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 ...
