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CDER, C-Path Acute Kidney Injury Project

[ Price : $8.95]

CDER and the Critical Path Institute say they are launching an acute kidney injury project to develop prognostic tools.

FDA Republishes OTC Monograph Fee Rates

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FDA republishes OTC monograph user fees for FY 2021 to exclude some facilities producing hand sanitizer during the pandemic.

Barostim Neo Regulatory Review Determined

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for CVRxs Barostim Neo, indicat...

Product-specific Bioequivalence Guides Availability

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that discuss the design...

FDA Seeks Consumer Reps on Advisory Panels

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Federal Register notice: FDA requests that any consumer organizations interested in participating in the selection of voting and n...

Rapid Medical Clot Retriever Clearance

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FDA clears a Rapid Medical 510(k) for its TigerTriever revascularization device for use in treating ischemic stroke.

Serono Comments on Planned FDA Disease Progression Workshop

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EMD Serono suggests three topics for FDA consideration for an upcoming workshop on best practices for developing and applying dise...

Objectionable Conditions at Nevada Clinical Study Site

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FDA cautions Michael Levin for violations in his work as a clinical investigator for a clinical study.

FDA Clears Aurora Spine Cervical Plate

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FDA clears an Aurora Spine 510(k) for its proprietary Apollo Anterior Cervical Plate system, featuring a 1.9mm design with hyper-a...

FDA Requires Guillain-Barr Warning in Shingrix Labeling

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FDA requires Glaxo to add information to the Shingrix labeling on an association between the shingles vaccine and Guillain-Barr Sy...