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QApel Selling Unapproved Aspiration System: FDA

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FDA warns Fremont, CA-based QApel Medical about illegally marketing an aspiration system with Quality System Regulation violations...

One-third of MAUDE Reports Submitted Late: Study

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Researchers say that nearly one-third of adverse event reports submitted to the FDA MAUDE medical device database came in later th...

Senate Committee Advances Makarys FDA Nomination

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The Senate Health Education Labor and Pensions Committee votes to advance the nomination of Marty Makary as FDA commissioner.

Returning FDA Staff to Face Space, Parking Issues

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FDA warns staff returning to offices on 3/17 that they can face parking and workspace issues, Reuters reports.

Canon Medical Gets AI Cleared for CT Scanner

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FDA clears a Canon Medical 510(k) for artificial intelligence enhancements for the Aquilion One/Insight Edition CT scanner.

Merck Reports Positive Data on HIV Trials

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Merck says it will seek FDA approval for new HIV regimen following its announcement of positive results from two pivotal Phase 3 t...

DoJ Lawyer Tapped as FDA Chief Counsel

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HHS appoints Justice Department attorney Hilary Perkins to serve as FDA chief counsel.

J&Js Monarch Quest Bronchoscopy Navigation Cleared

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FDA clears a Johnson & Johnson MedTech 510(k) for its Monarch Quest, an advanced navigation technology for robotically assisted br...

Comments Reopened on Good Clinical Practice Guide

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Federal Register notice: FDA reopens the comment period for its draft guidance entitled E6(R3) Good Clinical Practice: Annex 2.

Priority Review for DMD Cardiomyopathy BLA

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FDA accepts for priority review an NS Pharma BLA for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy c...