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Medical Devices

Tusker Medical Ear Infection Tubes Approved

FDA approves a Tusker Medical PMA for the Tubes Under Local Anesthesia System for delivery of tympanostomy tubes (ear tubes) that can be inserted into...

Bipartisan Call to Update 21st Century Cures Act

Reps. Upton and DeGette start a process to improve the 21st Century Cures Act.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes EPH Technologies and Lohxa.

FDA General

FDA Reflection This Thanksgiving: Alliance

As families sit down for Thanksgiving meals, the Alliance for a Stronger FDA says consideration should be given to FDA staff for their work in assurin...

Human Drugs

Adverse Event Reports Vary in Completeness

University of Tokyo researchers say that adverse events reports submitted to FDA vary in completeness depending on the occupation of the person submit...

Human Drugs

Teva, Others Try to Resolve Price-Fixing Probe

Bloomberg News says the federal government and several generic drug companies have been in discussions to resolve an ongoing antitrust price-fixing in...

Human Drugs

Invokana Could Change DKD Treatment: Spherix

Spherix Global Insights says FDA approval of a new indication for Janssens Type 2 diabetes drug Invokana to slow the progression of diabetic kidney di...

FDA General

Vasisht Named Associate Commissioner for Womens Health

FDA names Kaveeta Visisht to be associate commissioner for womens health.

Medical Devices

New FDA Efforts on Device EtO Sterilization

FDA announces its Ethylene Oxide Sterilization Master File Pilot Program that is intended to allow companies that sterilize single-use medical devices...

Federal Register

FDA Guidances for Generic Drug Developers

Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug developers.