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SCOTUS May Tighten Chevron Deference: Attorneys

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Two Axinn attorneys say there will be a flood of cases challenging federal agency decisions and interpretations of law if the Supr...

CDRH Sets Marketing Authorization Record

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The CDRH 2023 annual report says the Center approved the most novel devices in its history.

U.S. Reassures Canada on Drug Imports

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Canada health minister Mark Holland says he has been assured by top U.S. officials that the U.S. does not intend to harm Canadas d...

IVD Director Timothy Stenzel Retires

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CDRH Office of In Vitro Diagnostics director Timothy Stenzel retires after almost six years as head of diagnostic devices.

Package Level Drug Distribution Security Guidance

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FDA publishes a guidance on enhanced drug distribution security at the package level.

Satsuma Complete Response on Migraine Drug

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FDA sends Satsuma Pharmaceuticals a complete response letter on its NDA for STS101 (dihydroergotamine nasal powder), an investigat...

Percussionaire Recalls Ventilator Part

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Percussionaire recalls its Distal Phasitron, part: S20020, for use with the Percussionaire VDR-4 ventilator control driver due to ...

Megadyne Mega Soft Electrode Recall is Class 1

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FDA says the Megadyne recall of four models of patient return electrodes following reports of patient burns is Class 1.

GAO Probing FDA Ventilator Recall Actions

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The Pittsburgh Post-Gazette says GAO has accepted a request from two senators to look into FDA oversight of medical device adverse...

Reducing the Potential for Pulse Oximeter Bias

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Two stakeholders raise concerns about an FDA discussion paper on guidelines for pulse oximeters that consider skin pigmentation, r...