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Xbrane Refiles Lucentis Biosimilar BLA

[ Price : $8.95]

Xbrane Biopharma refiles a BLA for its investigational ranibizumab, a biosimilar copy of Genentechs age-related macular degenerati...

Alert on AquaFlexFlow Blood Circuits

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FDA issues a safety alert on Nuwellis AquaFlexFlow UF 500 Plus extracorporeal blood circuit because the device may trigger a weigh...

Senators Introduce Skinny Label Generic Drug Bill

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Four senators introduce bipartisan legislation to protect generic drug manufacturers from innovator drug lawsuits over skinny labe...

Sombra Cosmetics CGMP Violations

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FDA warns Albuquerque, NM-based Sombra Cosmetics about CGMP violations in the manufacturing of finished drugs.

FDA OKs Mesoblasts Ryoncil Cell Therapy

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FDA approves Mesoblasts Ryoncil to treat some graft-versus-host disease pediatric patients.

Clinical Investigation Protocol Deviations

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FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.

Updated POLARx Instructions is Class 1 Recall: FDA

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FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.

CGMP Violations in Akorn Formulations Review

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FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for...

Multiple Violations in BD Inspection

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FDA warns Becton Dickinson about multiple violations at its San Diego facility that manufactures the Pyxis Medication Management S...

ICH M15 Model-Informed Drug Development Principles

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FDA publishes an International Council for Harmonization draft M15 guidance on model-informed drug development principles.