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FDA Warns About Using RoyalVibe Ultrasounds

[ Price : $8.95]

FDA issues a warning against using ultrasound medical devices manufactured and distributed by RoyalVibe Health, and related compan...

Lilly Alzheimers Drug Slowed Decline by 35%

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Eli Lilly reports study results showing that donanemab significantly slowed cognitive and functional decline in people with early ...

BridgeBio Plans NDA for Cardiomyopathy Drug

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BridgeBio Pharma plans to file an NDA after reporting positive results from ATTRibute-CM, a Phase 3 study of acoramidis in transth...

Nonvoting Industry Reps for CDER Panels Sought

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Federal Register notice: FDA seeks industry organizations interested in participating in the selection of nonvoting industry repre...

Participants Sought for Patient Engagement Group

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Federal Register notice: FDA and the Clinical Trials Transformation Initiative seek patient advocates interested in participating ...

Fresenius Kabi Facility Hit With FDA-483

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FDA issues Fresenius Kabis Canton, MA outsourcing facility a Form FDA-483 over GMP deviations observed during a March inspection.

MedRhythms Stroke Neurorehabilitation System Cleared

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FDA clears a MedRhythms 510(k) for InTandem, a neurorehabilitation system to improve walking and ambulation in stroke patients.

EarliTec Autism Second Gen Device Cleared

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FDA clears an EarliTec Diagnostics 510(k) for the second generation of its EarliPoint Evaluation for Autism Spectrum Disorder in c...

Bill Introduced on Biosimilar Substitutions

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Senators Mike Lee (R-UT), Ben Ray Lujn (D-NM), Mike Braun (R-IN), and J.D. Vance (R-OH) introduce a bill to ease biosimilar interc...

Guide on Cell, Gene Therapy Manufacturing Changes

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Federal Register notice: FDA makes available a draft guidance entitled Manufacturing Changes and Comparability for Human Cellular ...