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QS Violations at Czech Device Firm

[ Price : $8.95]

FDA warns Czechias Deymed Diagnostic about QS violations in its production of non-sterile Class 2 medical devices.

Significant CGMP Violations in Prime Lab LLC

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FDA warns Ponce, Puerto Rico-based Prime Labs about significant CGMP regulation violations in its production of finished drugs.

Leiters Health Recalls Superpotent IV Bags

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Leiters Health recalls 33 lots of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags due to the potential for superpo...

Vertex Gets Priority Voucher

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Federal Register notice: FDA issues a priority review voucher (pediatric disease product) to Vertex Pharmaceuticals for gaining ap...

Bausch + Lomb Excimer Laser Approved

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FDA approves Bausch + Lombs Teneo Excimer Laser Platform for LASIK vision correction surgery for myopia and myopic astigmatism.

FDA OKs Medtronics Brain Stimulator

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FDA approves a Medtronic PMA for its Percept RC Deep Brain Stimulation system.

First-Cycle Drug Approvals Improve: Report

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CDER first-cycle drug approvals last year shot up to 84% (46 of 55 NDAs) from 76% (28 of 37 NDAs) in 2022, according to a just-rel...

FDA Endorses Vaporized Hydrogen Peroxide

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FDA endorses vaporized hydrogen peroxide to be an established sterilization method for medical devices.

Info Collection on Drug Expedited Programs

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Federal Register notice: FDA seeks comments on an information collection extension entitled Expedited Programs for Serious Conditi...

Megadyne Recalls Patient Return Electrodes

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Megadyne Medical Product recalls its Mega Soft Universal Patient Return Electrodes to update its Instructions for Use and product ...