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Novocure PMA Filed for Lung Cancer

[ Price : $8.95]

FDA accepts for review a Novocure PMA that seeks approval for the use of tumor treating fields therapy together with standard syst...

FDA, CMS Reiterate Need for FDA Test Oversight

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FDA and CMS officials call for support of an FDA proposal to regulate laboratory-developed tests.

IRB Waiver Info Collection Approved

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Federal Register notice: OMB approves an information collection entitled Institutional Review Board Waiver or Alteration of Inform...

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 ...