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FDA Clears Think Surgical Robotic Knee Replacement

[ Price : $8.95]

FDA clears a Think Surgical 510(k) for the TSolution One Total Knee Application for use in total knee arthroplasty.

JAMA Article Raises Doubt on Replicating Trials

[ Price : $8.95]

A new study in JAMA suggests there is limited feasibility for the idea of replicating clinical trials using real-world evidence.

FDA Clears Turn Therapeutics Wound Dressing

[ Price : $8.95]

FDA clears a Turn Therapeutics 510(k) for the Protego Antimicrobial Wound Dressing.

7 Observations on Aurobindo FDA-483

[ Price : $8.95]

FDA releases an FDA-483 with seven observations from an inspection at an Aurobindo finished drug manufacturing facility.

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.