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Change Device Enforcement Guide: AdvaMedDx

[ Price : $8.95]

AdvaMedDx calls for two substantive changes to an FDA draft guidance on the enforcement policy for certain in vitro diagnostic dev...

Orphan Status for Green Tea Extract in Pouchitis

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FDA grants PharmasstX an orphan drug designation for epigallocatechin gallate, a green tea extract for treating inflammatory bowel...

30 1st Quarter Serious Risk Signals

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FDA posts 30 signals of serious risks/new safety information identified by the FAERS in the first quarter of 2024 and is evaluatin...

FDA OKs Cordis Vascular Closure Device

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FDA approves a Cordis PMA for its Mynx Control Venous Vascular Closure Device for use in certain cardiac ablation procedures.

Dont Use Medtronic NIM EMG Endotracheal Tubes: FDA

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FDA cautions healthcare providers and facilities to heed a Medtronic urgent recall of all models and lots of its NIM EMG Contact a...

UniQure Seeking Accelerated Approval Path for Gene Therapy

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UniQure says it will meet soon with FDA to discuss potential expedited clinical development pathways and accelerated approval afte...

CGMP Violations at S. Koreas ReBom Co.

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FDA warns South Koreas ReBom Co. about CGMP violations in its manufacturing of OTC drugs.

Inspire Recalls Implantable Pulse Generator

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Inspire Medical Systems recalls its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect that can...

Draft Guide on Addressing Product Misinformation

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Federal Register notice: FDA makes available a revised draft guidance entitled Addressing Misinformation About Medical Devices and...

Draft Guide on Use-Related Risk Analyses

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Federal Register notice: FDA makes available a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs,...