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FDA, Guided Therapeutics Agree on LuViva PMA Path

[ Price : $8.95]

Guided Therapeutics says it has reached a general agreement with FDA on a process to collect data for a PMA submission for its LuV...

AbbVie NDA Filed for Once-daily Viekira Pak

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AbbVie files an NDA for a once-daily, fixed-dose formulation of the components of Viekira Pak (ombitasvir, paritaprevir, and riton...

Lesser-known Preemption Arguments

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Attorney James Beck reviews three court decisions based on lesser-known preemption arguments.

QS Violations at WalkMed Infusion

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FDAs Denver District Office warns WalkMed Infusion about Quality System and other violations in its manufacturing of infusion pump...

Objectionable Conditions at Nvision Eye Center

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FDA warns Nvision Laser Eye Centers about objectionable conditions in its conduct of research on an investigational new drug.

FDA Clears Caputron Medical Brain Stimulator

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FDA clears a Caputron Medical 510(k) for its mindGear headset for treating depression, insomnia and anxiety.

Bank False Claims Case Can Affect Healthcare Suits

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Two Epstein Becker Green attorneys write that a False Claims Act case involving a manufacturing firm making allegedly false certif...

GCP Audits Look at Research Quality

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The FDA Group says that independent Good Clinical Practice audits help ensure that clinical trial subjects rights are respected an...

Bestmed Recalls Faulty Digital Thermometers

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Bestmed recalls its Digital Temple Thermometer Model No. KD-2201 manufactured by K-Jump Health Co. due to a manufacturing problem ...

Innovative Trial Design Proposal Discussed at PDUFA Meeting

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A drug industry proposal at a PDUFA negotiation meeting seeks FDA processes to facilitate appropriate use of innovative clinical t...