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Medical Device User Fee Rates Posted

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Federal Register Notice: FDA announces the fee rates and payment procedures for fiscal year 2017 medical device user fees.

Guidance on General Wellness Devices

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Federal Register Notice: FDA releases a guidance: General Wellness: Policy for Low Risk Devices.

FDA Delays Review Action on BioMarin NDA

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FDA tells BioMarin that it has not yet completed the review process for its NDA on Kyndrisa (drisapersen) and it will not take an ...

FDA Approves Fecal Continence Device

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FDA approves a Torax Medical humanitarian device exemption for the Fenix Continence Restoration System to treat fecal incontinence...

FDA Clears GI Logic AbStats System

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FDA clears a GI Logic 510(k) for the AbStats System to be used by physicians in hospitals and other healthcare settings for real t...

Congress Suspends Medical Device Tax

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Congress approves a budget and tax deal that will suspend the 2.3% medical device excise tax that has been in effect since 1/2013.

Industry Seeks More Clarity on Flexible Regulatory Approaches

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Pharmaceutical Research and Manufacturers of America and Pfizer comment on a draft guidance on Rare Diseases: Common Issues in Dru...

FDA Clears Luminex Respiratory Pathogen Assay

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FDA clears a Luminex 510(k) for its NxTAG Respiratory Pathogen Panel that detects 20 clinically relevant viral and bacterial respi...

CDER Seeks e-Health Record Projects

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CDER requests demonstration projects to test the capability and evaluate performance of using an end-to-end Electronic Health Reco...

Review Period Set for Xtandi

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Federal Register Notice: FDA determines that regulatory review period Xtandi for the purpose of patent extension.