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FDA clears a Bioporto 510(k) for its ProNephro AKI (NGAL) biomarker assay for detecting pediatric acute kidney injury.[ Price : $8.95]
FDA rejects an Oncopeptides appeal seeking to stop a CBER request for the company to voluntarily withdraw its accelerated-approved...[ Price : $8.95]
FDA says it has responded to a Universities Allied for Essential Medicines by creating a dashboard of Clinical Trials.gov pre-noti...[ Price : $8.95]
FDA clears a ClearPoint Neuro 510(k) for use of its ClearPoint 2.2 software with the integrated Maestro Brain Modeling.[ Price : $8.95]
FDA clears a Zimmer Biomet 510(k) for the ROSA Shoulder System for robotic-assisted shoulder replacement surgery.[ Price : $8.95]
Industry stakeholders question the usefulness and design of proposed CDER Office of Prescription Drug Promotion research into impl...[ Price : $8.95]
The CDER Office of Generic Drugs 2023 annual report details the 956 ANDAs approved or tentatively approved last year.[ Price : $8.95]
Two Hogan Lovells attorneys and two Greenleaf Health executives discuss FDA actions in this election year at a recent J.P. Morgan ...