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Vanda Sues FDA Over Pending Tradipitant NDA Decision

[ Price : $8.95]

Vanda Pharmaceuticals sues FDA, seeking an advisory committee meeting to assess the companys pending NDA for tradipitant and its u...

Zynex TensWave for Pain Cleared

[ Price : $8.95]

FDA clears a Zynex 510(k) for its TensWave, a transcutaneous electrical nerve stimulation therapy for reducing chronic and acute p...

Ventis Emergency Transport Ventilator Cleared

[ Price : $8.95]

FDA clears a Ventis Medical 510(k) for the VM-2000, an emergency transport ventilator that allows medical personnel to provide res...

Roche Cobas Covid/Flu Test EUA Revoked

[ Price : $8.95]

Federal Register notice: FDA revokes a 2020 emergency use authorization granted to Roche Molecular Systems for the cobas SARS-CoV2...

Intervertebral Body Graft Devices are Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies intervertebral body graft containment devices into Class 2 (special controls).

Atlanta Doctors Research Didnt Follow Plan: FDA

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FDA warns Atlanta, GA-based physician Julio Flamini about concerns related to investigations at his Clinical Integrative Research ...

Company Illegally Marketing Stem Cells: FDA

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FDA warns Coral Gables, FL-based Mother Stem Institute about illegally marketing stromal vascular fraction products derived from d...

PhRMA Wants Changes to Platform Tech Designation

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PhRMA makes nine recommendations for changes to an FDA draft guidance on the platform technology designation program.

Correct Misleading AbbVie Study Description: Ali

[ Price : $8.95]

Ali Pharmaceutical asks FDA to require AbbVie to stop saying it is using Alis Armour Thyroid in a clinical trial since it is using...

Many Ideas to Approve FDA Regulation of AI: Article

[ Price : $8.95]

Politico explores the many ideas people have for improving FDFA regulation of artificial intelligence.