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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 ...

FDA Posts FDA-483s from 2 Indian Companies

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FDA releases the forms FDA-483 with multiple observations from inspections at Granules India Limited and Gland Pharma, both drug m...

Firms Seek Broad Extrapolation for Pediatric IBD Dosing

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Joint comments from three major drug companies about pediatric inflammatory bowel disease drug development question why FDA does n...

Rubio, King Push FDA on Advanced Drug Manufacturing

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Sens. Rubio and King push FDA to quickly finish implementing the Advanced Manufacturing Technologies Designation Program so indust...