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CAR T-Cell Benefits Outweigh Risks: Marks

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CBER director Peter Marks says there is a positive risk/benefit assessment for CAR-T therapy for its approved uses.

Jungman to be Califf Chief of Staff

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CDER director Patrizia Cavazzoni says ORP director Elizabeth Jungman will become FDA commissioner Robert Califfs chief of staff.

Potential Chemical Exposure in GE Compressors

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FDA cautions that there is the potential for elevated levels of formaldehyde being released when two GE HealthCare compressors are...

QS Violations at Czech Device Firm

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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...