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Topical Xylocaine Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Fresenius Kabis Xylocaine (lidocaine hydrochloride) topical solution 4% was not withd...

Therapeutic Equivalence Evaluation Guidance

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FDA publishes a draft guidance on therapeutic equivalence evaluations.

Comments on ICH Quality Risk Management Guidance

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Five stakeholders recommend changes to an International Council for Harmonization revised quality risk management guidance.

Sentinel May be Useful in Short Latency Cancer: Study

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Researchers say the FDA Sentinel System may provide useful real-world data for cancer drug safety studies.

Smiths Medical Recall of Infusion Pumps is Class 1

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FDA classifies as Class 1 a Smiths Medical recall of its Medfusion 3500 and 4000 Syringe Infusion Pumps due to eight software malf...

CDER Sampling/Testing Program Explained

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CDER Office of Quality Surveillance director Jennifer Maguire explains the agencys surveillance testing and sampling program.

Soleno Study Change Might Answer Questions: FDA

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FDA tells Soleno Therapeutics that a change in study design for its Prader-Willi treatment NDA has the potential to answer agency ...

Draft Dose Banding Guidance Out

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FDA publishes a draft drug banding guidance.

FDA Warning on Ultraviolet Wands for Disinfecting

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FDA issues a safety warning about certain brands of ultraviolet wands used for disinfecting surfaces because the devices may expos...

Many Drug Field Contacts In Person Again: Veeva Report

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The Veeva Field Trends 2022 report says 75% of healthcare providers want contact with drug field staff to be a mix of digital and ...