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FDA Denies Hearing on CDER Denial of Oxycodone NDA

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Federal Register notice: FDAs chief scientist denies a request for a hearing on a CDER proposal to refuse approval of a Pharmaceut...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Boule Medical, Cardiomed Supplies, Gaeltec Devices and Leventon.

QS Violations Seen in Leventon Inspection

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FDA warns Spains Leventon S.A.U. about Quality System violations in its manufacturing of Dosi Flow infusion pumps and administrati...

Warnings Sought on Isotretinoin Sexual Effects

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Three medical school professors ask FDA to add warning language about sexual side effects to labeling for all drug products contai...

Bone Conduction Hearing System into Class 2

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Federal Register notice: FDA classifies the active implantable bone conduction hearing system into Class 2 (special controls).

Class 2 for Humidified Oxygen Delivery Devices

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Federal Register notice: FDA classifies high-flow humidified oxygen delivery devices into Class 2 (special controls).

Rebinyn Regulatory Review Period Determined

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Novo Nordisks Rebin...

Align Technology Gains Clearance for Revised Invisalign

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FDA clears an Align Technology 510(k) for the Invisalign treatment with mandibular advancement, a clear aligner solution for Class...

Research Mulls Approach to Qualify Patient-reported Measures

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New research supported by CDRHs Division of Biostatistics outlines an approach that could lead to more patient-reported outcome me...

Circulatory System Device Panel to Meet 12/4-5

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Federal Register notice: FDA announces a12/4-5 Circulatory System Devices Panel of the Medical Devices Advisory Committee.