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Zogenix Review Extension for Dravet Syndrome Drug

[ Price : $8.95]

FDA extends by three months its review of a Zogenix NDA for Fintepla (fenfluramine oral solution) for treating seizures associated...

Framework for Device Real-World Evidence Studies

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NESTcc publishes its data quality framework and methods framework for use in real-world evidence studies.

American Health Packaging Recalls Some Ranitidine for NDMA

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American Health Packaging recalls 11 lots of ranitidine tablet unit dose blisters due to potential NDMA contamination.

Panel Delivers Mixed Vote on Lillys Cyramza

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FDAs Oncologic Drugs Advisory Committee delivers a mixed vote (six to five) to support approval of Eli Lillys supplemental BLA for...

King Visions Video Laryngoscope Class 1 Recall

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FDA classifies as Class 1 a King Systems recall of its King Vision Video Laryngoscope (adapter size 1/2) because they may display ...

Device Spot Shortages Reported to FDA

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FDA says it has received reports of spot shortages of some medical devices due to the global coronavirus outbreak.

CPAP Cleaning Safety Communication

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FDA cautions against using unapproved products that claim to clean CPAP machines and accessories with ozone gas or UV light.

Judge Orders Old Clinical Trial Info Posted

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A New York federal judge rules that 10 years of clinical trial information that HHS said did not have to be filed at ClinicalTrial...

FDA OKs Acacia Nausea Drug

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FDA approves an Acacia Pharma Group NDA for Barhemsys (amisulpride injection) for preventing and treating postoperative nausea and...

OIG Sees Medical Device, Drug Risks

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HHS deputy inspector general Suzanne Murrin tells House Appropriations Committee members there are steps FDA can take to reduce me...