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QS, MDR Issues at Taiwans Visgeneer

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FDA warns Taiwans Visgeneer, Inc., about Quality System and Medical Device Reporting violations in its manufacturing of blood gluc...

Medical Device PFAS Appear Safe: FDA

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FDA issues an online post describing the safety to patients of the type of PFAS used in medical devices.

BMS Files Breyanzi Marginal Zone Lymphoma sBLA

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FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel; liso-cel) as a pot...

Lantheus NDA for Pylarify New Formulation

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FDA accepts a Lantheus NDA for a new formulation of its Pylarify F 18 prostate-specific membrane antigen imaging agent.

FDA Publishes Data Standards Program Update

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FDA publishes the FY 2025 Quarter 2 update to the CBER/CDER Data Standards Program Action Plan.

Clarametyx Gets Fast Track for Pulmonary Infection Drug

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FDA grants Clarametyx Biosciences both fast track and qualified infectious disease product designations for its lead therapeutic c...

Mectronic Medicale Multiple Violations

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FDA warns Italys Mectronic Medicale about Quality System, Medical Device Reporting, and other violations in its illegal manufactur...

Two-Day Workshop on Oncology Patient Registries

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FDAs Oncology Center of Excellence announces a two-day virtual public workshop to advance the development of patient registries in...

CGMP Violations at Oasis Medical

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FDA warns Glendora, CA-based Oasis Medical about CGMP violations in its production of finished drugs.

Laura Loomer Targets Makary Over Prasad Exit

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Right-wing commentator Laura Loomer publicly criticizes FDA commissioner Marty Makary over recent comments surrounding the departu...