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FDA Expanding CURE ID

[ Price : $8.95]

An FDA podcast reports ways in which the CURE ID app is being expanded beyond infectious diseases.

Guide on Drug DNA Reactive Impurities

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Federal Register notice: FDA makes available a final guidance entitled M7(R2) Assessment and Control of DNA Reactive (Mutagenic) I...

12 Catalent Inspection Observations

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FDA releases the form FDA-483 with 12 observations from an inspection at the Bloomington, IN-based Catalent Indiana sterile drug a...

FDA Told: Generally Accepted Often Isnt

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Three stakeholders raise concerns about an FDA draft guidance on using generally accepted scientific knowledge in drug and biologi...

Meridian Bios H. pylori Test Cleared

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FDA clears a Meridian Bioscience 510(k) for its Premier HpSA FLEX for diagnosing Helicobacter pylori.

Beckman Coulter Chemistry Analyzer Cleared

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FDA clears a Beckman Coulter 510(k) for its DxC 500 AU Chemistry Analyzer, an automated analyzer intended for use by small-to-medi...

FDA Downplays Impact After Pfizer Tornado

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FDA says it does not expect any immediate impact on drug supplies due to tornado damage at Pfizers Rocky Mount, NC sterile drug ma...

ICH Mutagenic Impurities Drug Guidance

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FDA posts an International Council for Harmonization-developed guidance entitled M7(R2) Assessment and Control of DNA Reactive (Mu...

FDA Spending Bill Will See Veto: White House

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The Biden Administration threatens to veto a House spending measure that includes cuts to FDAs budget.

Syndax/Incyte Plan BLA for Axatilimab

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Syndax Pharmaceuticals and Incyte plan to file by the end of the year a BLA for axatilimab, for use in adult and pediatric patient...