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Medical Devices

Guide on Denture Resin Performance Criteria

FDA posts a draft guidance entitled Denture Base Resins Performance Criteria for Safety and Performance Based Pathway.

Medical Devices

Study Confirms Cell Phone Magnetic Interference

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

Medical Devices

FDA OKs Vagus Nerve Stimulation for Stroke Patients

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

Federal Register

Nonprescription Drugs Panel Renewed for 2 Years

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

Federal Register

Circulatory System Panel Meeting on Endovascular Grafts

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

Federal Register

Panel to Vote on Integra LifeSciences Breast Reconstruction

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

Human Drugs

Cumberland Recruiting MS Study Participants

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

FDA General

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

Federal Register notice: FDA makes available a draft guidance entitled Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Pr...

Human Drugs

FDA Approves Expanded Age for Ironwoods Linzess

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

Medical Devices

Court Tosses Boston Scientific Whistleblower Case

Three Sidley Austin attorneys describe a Minnesota federal court decision rejecting a whistleblowers claims that Boston Scientific fraudulently induce...