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Device Sterilization Master File Pilot

[ Price : $8.95]

Federal Register notice: CDRH announces an Ethylene Oxide Sterilization Master File Pilot Program that will allow sterilization pr...

Tobacco Product Modifications Compliance Policy

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance entitled Compliance Policy for Limited Modifications to Certain Marketed T...

Tusker Medical Ear Infection Tubes Approved

[ Price : $8.95]

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

Bipartisan Call to Update 21st Century Cures Act

[ Price : $8.95]

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

Latest FDA Warning Letters

[ Price : $8.95]

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

FDA Reflection This Thanksgiving: Alliance

[ Price : $8.95]

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

Adverse Event Reports Vary in Completeness

[ Price : $8.95]

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

Teva, Others Try to Resolve Price-Fixing Probe

[ Price : $8.95]

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

Invokana Could Change DKD Treatment: Spherix

[ Price : $8.95]

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

Vasisht Named Associate Commissioner for Womens Health

[ Price : $8.95]

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