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AdvaMed Supports Diagnostics Reforms in User Fee Reauthorization

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The Advanced Medical Technology Association urges the House and Senate to come to terms on a FDA user fee reauthorization package ...

Panel to Discuss Certain Accelerated Approvals

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Federal Register notice: FDA announces a 9/22-23 Oncologic Drugs Advisory Committee meeting that will discuss an NDA for Spectrum ...

Topical Xylocaine Not Withdrawn Due to Safety/Efficacy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FDA publishes a draft guidance on therapeutic equivalence evaluations.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.