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FDA Warns Overseas OTC Manufacturers

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FDA warns six overseas manufacturers of over-the-counter drugs about CGMP violations.

CBER Allowing Device In-Person Meetings

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CBER begins a phased implementation of in-person industry meetings with device manufacturers.

BIO Supports FDAs AI/ML Discussion

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The Biotechnology Innovation Organization says it supports FDA efforts to promote stakeholder discussion on the role of artificial...

Wegovy Hits Trial MACE Goal

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Novo Nordisk says its Wegovy cut the risk of major adverse cardiovascular events by 20% in overweight or obese adults in the SELEC...

FDA OKs Boston Scientific Cryoablation Device

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FDA approves a Boston Scientific PMA for the POLARx Cryoablation System for treating patients with paroxysmal atrial fibrillation.

QTc Labeling Information Guidance

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FDA publishes a draft guidance on incorporating QTc prolongation-related information in drug and biological product labeling.

Cubicin Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Cubist Pharmaceuticals Cubicin and Cubicin RF (daptomycin) powder for injection were ...

Comments Sought on 8 Drugs for WHO Scheduling

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Federal Register notice: FDA seeks comments concerning abuse potential and the impact of scheduling changes on availability for me...

Guide on Nitrosamine Acceptable Intake Limits

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Federal Register notice: FDA makes available a final guidance entitled Recommended Acceptable Intake Limits for Nitrosamine Drug S...

Drger Recalls Carina Ventilators

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Drgerwerk recalls its Drger Carina Sub-Acute Care Ventilators due to the potential for contamination of the breathing gas.