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Appropriators Slash FDA Budget by $450 Million

[ Price : $8.95]

A House Appropriations subcommittee slashes $450 million (6%) from FDAs fiscal year 2025 budget.

FDA Clears Avicenna.AIs Vertebral Fracture Detector

[ Price : $8.95]

FDA clears an Avicenna.AI 510(k) for its CINA-VCF, a triage and notification artificial intelligence tool for detecting unsuspecte...

Getinge Clinical Decision Support Software Cleared

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FDA clears a Getinge 510(k) for its innovative clinical decision support software Talis +ACG (Advanced Clinical Guidance).

Spinal Simplicity Anterior Cervical Plate Cleared

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FDA clears a Spinal Simplicity 510(k) for its Wolffs Law Anterior Cervical Plate System.

CGMP Violations at Malaysias TCT Neutraceuticals

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FDA warns Malaysias TCT Neutraceuticals about CGMP violations in its manufacturing of OTC drugs.

CDER AI Pharmacovigilance Meeting Program

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Federal Register notice: CDER announces the Emerging Drug Safety Technology Meeting program for stakeholders to discuss the use of...

Insulet Recalls Omnipod DASH Insulin Manager

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Insulet recalls (Class 1) its Omnipod DASH Insulin Management Systems Personal Diabetes Manager after receiving reports battery is...

Cosmetic Solutions CGMP, Unapproved Drug Violations

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FDA warns Boca Raton, FL-based Cosmetic Solutions about CGMP and unapproved new drug violations in its manufacturing of finished d...

Drug QA Inspections Up 40%: Report

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The Office of Pharmaceutical Quality FY 2023 annual report says drug quality assurance inspections were up 40% over FY 2022 and mu...

Upcoming CDRH eMDR Enhancements

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FDA lists three planned 2024 enhancements to the CDRH electronic medical device reporting system.