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GSK Scraps Monoclonal Antibody Development for RA

[ Price : $8.95]

GSK decides not to seek FDA approval for otilimab, an investigational monoclonal antibody targeting granulocyte-macrophage colony-...

Info Collection on 3rd Party Review Program

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Federal Register notice: FDA sends to OMB an information collection extension entitled 510(k) Third-Party Review Program.

Panel Mixed on GSK Anemia Drug Due to Safety

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An FDA advisory committee votes to recommend approval of GlaxoSmithKlines anemia drug daprodustat for use in treating chronic kidn...

California Court Upholds Preemption for Medtronic

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Attorney Michelle Yeary says a California state court granted Medtronic summary judgment on several product liability claims invol...

Ashley Retiring as CDER Compliance Director

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FDA announces the retirement of CDER Office of Compliance director Don Ashley.

FDA Looking at Marijuana Scheduling Flexibility: Woodcock

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FDA principal deputy commissioner Janet Woodcock says the agency is exploring what flexibility it has in reviewing the science and...

EUA Granted for Abbott Monkeypox Diagnostic

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Federal Register notice: FDA announces an Emergency Use Authorization for Abbott Molecular and its Alinity m MPXV monkeypox diagno...

Guide on C-diff Infection Drug Development

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FDA makes available a draft guidance entitled Clostridioides difficile Infection (CDI): Developing Drugs for Treatment, Reduction ...

FY 2023 GDUFA Research Priorities

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FDA posts eight generic drug research priority initiatives for FY 2023.

Baxter WatchCare Urgent Correction

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FDA says Baxter International has issued an urgent medical device correction for its WatchCare incontinence system that may cause ...