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Guide on Facet Screw Systems Performance Criteria

[ Price : $8.95]

FDA posts a draft guidance entitled Facet Screw Systems Performance Criteria for Safety and Performance Based Pathway.

Guide on Denture Resin Performance Criteria

[ Price : $8.95]

FDA posts a draft guidance entitled Denture Base Resins Performance Criteria for Safety and Performance Based Pathway.

Study Confirms Cell Phone Magnetic Interference

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A new study by FDA researchers supports an agency recommendation earlier this year that patients keep any consumer electronic devi...

FDA OKs Vagus Nerve Stimulation for Stroke Patients

[ Price : $8.95]

FDA approves a MicroTransponder PMA for the Vivistim Paired VNS System, a vagus nerve stimulation device intended to treat moderat...

Nonprescription Drugs Panel Renewed for 2 Years

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Federal Register notice: FDA renews its Nonprescription Drugs Advisory Committee for an additional two years.

Circulatory System Panel Meeting on Endovascular Grafts

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Federal Register notice: FDA announces an 11/2-3 Medical Devices Advisory Committee Circulatory System Devices Panel meeting to di...

Panel to Vote on Integra LifeSciences Breast Reconstruction

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Federal Register notice: FDA announces a 10/20 advisory committee meeting to vote on a Integra LifeSciences PMA for the SurgiMend ...

Cumberland Recruiting MS Study Participants

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Cumberland Pharmaceuticals recruits patients for a Duchenne muscular dystrophy cardiomyopathy trial of ifetroban funded by FDA.

Draft Guide on PD-1, PD-L1 Alternative Dosing

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Federal Register notice: FDA makes available a draft guidance entitled Pharmacokinetic-Based Criteria for Supporting Alternative D...

FDA Approves Expanded Age for Ironwoods Linzess

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FDA approves a revised label for Ironwoods Linzess expanding the potential for off-label use in children under age 18.