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3 Observations on Lupin FDA-483

[ Price : $8.95]

FDA releases the FDA-483 with three observations issued following an inspection at a Lupin API manufacturing facility.

Info Collection Extension for Outsourcing Facilities

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension for electronic drug product reporting for drug com...

Final Guide on Intravascular Catheter Labeling

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Federal Register notice: FDA makes available a final guidance entitled Intravascular Catheters, Wires, and Delivery Systems with L...

FDA Works on Improved Vaccine Candidate

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FDA says its scientists have found a way to improve influenza candidate vaccine viruses.

Sky Medical Venous Thrombosis Device Cleared

[ Price : $8.95]

FDA clears a Sky Medical Technology 510(k) for its geko device for stimulation of the calf muscles to prevent venous thrombosis in...

New FDA-Track BsUFA Performance Dashboard Out

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FDA releases a dashboard to help view data on Biosimilar User Fee Act performance metrics.

Guide on Guidewire Testing and Labeling

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Federal Register notice: FDA makes available a final guidance on coronary, peripheral, and neurovascular guidewire testing and lab...

Final Guide on IVDs in Oncology Trials

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Federal Register notice: FDA makes available a final guidance entitled Investigational In Vitro Diagnostics in Oncology Trials: St...

FDA Clears OraSures Ebola Test

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FDA grants a de novo clearance for OraSure Technologiess OraQuick Ebola Rapid Antigen Test to detect Ebola virus antigens in human...

Comments on Inactive Ingredient Database Guidance

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Four stakeholders comment on an FDA draft guidance on its inactive ingredient database.