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Numares LDL Test for Cardiovascular Disease

[ Price : $8.95]

FDA clears a Numares Health 510(k) for the Axinon LDL-p Test System, a test physicians can use to measure lipoproteins for patient...

FY 2024 Device User Fee Rates Set

[ Price : $8.95]

FDA announces the FY 2024 user fee rates for medical device submissions.

Drug/Biologic User Fee Rates for FY 2024

[ Price : $8.95]

Federal Register notice: FDA announces the rates for prescription drug/biologic user fees for fiscal year 2024.

Senate Bill Introduced on Drug Shortages

[ Price : $8.95]

Three Democratic U.S. Senators introduce the Drug Shortages Prevention and Quality Improvement Act that would give FDA and CMS add...

FDA Expands Device TAP Pilot

[ Price : $8.95]

FDA expands the medical device Total Product Life Cycle Advisory Program pilot to include the Office of Neurological and Physical ...

Citius Pharma Gets Complete Response Letter

[ Price : $8.95]

FDA sends Citius Pharmaceuticals a complete response letter on its BLA seeking approval for Lymphir (denileukin diftitox), indicat...

Abbott Withdraws Trifecta Heart Valves

[ Price : $8.95]

Abbott decides to stop selling its Trifecta heart valves due to the potential risk of early structural valve deterioration.

Info Collection on Combo Product Jurisdiction

[ Price : $8.95]

Federal Register notice: FDA requests comments on an information collection extension entitled Product Jurisdiction and Combinatio...

Guide on Biosimilar User Fees

[ Price : $8.95]

FDA posts a final guidance entitled Assessing User Fees Under the Biosimilar User Fee Amendments (BUSFA 3) of 2022.

GE Recalls TruSignal SpO2 Sensors

[ Price : $8.95]

GE HealthCare recalls its TruSignal SpO2 Sensors due to malfunction issues that may reduce defibrillation energy or expose patient...