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FDA Remaking Inspection Priorities in Wake of Trump Cuts

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FDA says it is reprioritizing planned inspections for the rest of the year due to challenges it faces after 170 administrative and...

Medivis Spinal Navigation Device Cleared

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FDA clears a Medivis 510(k) for its Spine Navigation platform that uses augmented reality and artificial intelligence (AI) to assi...

FDA Says Rex Implants Illegally Marketing Devices

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FDA warns Columbus, OH-based Rex Implants that it is illegally manufacturing and distributing three medical devices.

Bausch + Lomb Recalls enVista Intraocular Lenses

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Bausch + Lomb recalls all enVista intraocular lenses due to increasing adverse event reports of toxic anterior segment syndrome as...

Axsome Solriamfetol Misses Primary Endpoint

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Axsome Therapeutics says its solriamfetol missed the primary endpoint in a Phase 3 proof-of-concept trial to treat major depressiv...

Compass Therapeutics Reports on Tovecimig Trial Data

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Compass Therapeutics reports statistically significant top-line data on the primary efficacy endpoint from its COMPANION-002 trial...

3 Observations on SKNV Outsourcing FDA-483

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FDA releases the form FDA-483 with three observations from an inspection at the Pompano Beach, FL-based SKNV outsourcing facility.

Multiple Violations in Next Science Inspection

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FDA warns Jacksonville, FL-based Next Science that it is illegally manufacturing and distributing adulterated and misbranded medic...

FDA in Upheaval as Staff Layoffs Begin

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HHS begins terminating FDA employees, with many receiving email notifications in the early morning hours or being denied entrance ...

Apellis Files Empaveli sNDA in Rare Kidney Diseases

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FDA accepts for priority review an Apellis Pharmaceuticals supplemental NDA for Empaveli (pegcetacoplan) for treating two severe a...