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Contaminated Atovaquone Recalled by Bionpharma

[ Price : $8.95]

Bionpharma recalls (Class 1) a single Batch (#2310083) of atovaquone oral suspension due to contamination with Cohnella bacteria.

Medical Device Biocompatibility Guidance

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FDA publishes a draft guidance with recommended chemical analyses for medical device biocompatibility assessment.

Device User Fee Cover Sheet Info Collections

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Federal Register notice: FDA submits to OMB information collection revisions entitled Medical Device User Fee Cover Sheet, Form FD...

RFK Jr. to Recommend Trump Health Agency Heads?

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Mainstream health gadfly Robert K. Kennedy, Jr., says he has been asked by Donald Trump to be heavily involved in choosing people ...

CDER Biosim. Interchangeability Change Explained

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CDER director Patrizia Cavazzoni and Office of Therapeutic Biologics and Biosimilars director Sarah Yim say a revised FDA guidance...

Elanco Gets Anti-Itch Zenrelia Approved for Dogs

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FDA approves Elanco Animal Healths Zenrelia (ilunocitinib tablets), a once-daily oral JAK inhibitor for controlling itching associ...

FDA Hits Spanish Drug Facility with 483

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FDA cites Laboratorios Farmaceuticos Rovi in a four-item Form FDA-484 after inspecting the companys Madrid, Spain manufacturing fa...

Device Measuring Neurologic State Cleared

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FDA clears a Forest Devices 510(k) for the SignalNED Model RE System, a device that uses electroencephalogram technology to assess...

Guide on Clinical Trials With Decentralized Elements

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Federal Register notice: FDA makes available a final guidance entitled Conducting Clinical Trials With Decentralized Elements that...

Braun Medical Expands Infusion Pump Recall

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Braun Medical expands an earlier recall to add lnfusomat Space Infusion System/Large Volume Pump to previous recalled devices due ...