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FDA Clears DePuys TriLEAP Plating

[ Price : $8.95]

FDA clears a DePuy Synthes 510(k) for the TriLEAP Lower Extremity Anatomic Plating System, a modular, procedure-specific device fo...

Multiple Violations in Abiomed Inspection

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FDA warns Danvers, MA-based Abiomed about Quality System, Medical Device Reporting, and other violations in its marketing of Impel...

2 Unapproved GLP-1 Drug Marketers Warned: FDA

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FDA issues Warning Letters to two online marketers promoting unapproved glucagon-like peptide-1 receptor agonists semaglutide and ...

Suggested Changes to Underrepresented Draft Guide

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Three stakeholder organizations suggest changes to an FDA draft guidance on postmarketing approaches to obtain data on populations...

14 Observations on Spectrum FDA-483

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FDA releases the form FDA-483 with 14 observations from an inspection at the New Brunswick, NJ-based Spectrum Laboratory Products ...

Minor Updates to 2 Magnetic Resonance Guidances

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FDA publishes minor updates to two magnetic resonance guidances to harmonize them with the latest consensus standards.

Researcher Cited for Objectionable Conditions

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FDA warns Miami, FL-based Dr. Antonio Blanco/Vista Health Research about conducting two clinical investigations in a way that did ...

FDA Cautions About Compounded Ketamine

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FDA lists several cautions it says patients and healthcare providers should be aware of when considering using compounded ketamine...

FDA QTc Draft Guidance Too Vague: NCHR

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The National Center for Health Research says an FDA draft guidance on QTc information in drug and biologic labeling is too vague t...

CDRH Plans 24 Guidances in FY 2024

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CDRH publishes a list of final and draft guidances to be published in FY 2024.