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Wound Dressing Change Kit Recalled

[ Price : $8.95]

ROi CPS of Republic, MO, recalls its Regard Wound Dressing change kit due to it containing nonconforming material/component.

Document on Guidance Best Practices

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Federal Register notice: FDA makes available a draft document entitled Food and Drug Administrations Draft Report and Plan on Best...

Latest Safety Signal Report Includes Ozempic, Others

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FDA says it is evaluating the need for regulatory action after seeing a safety signal for some additional side effects in GLP-1 re...

Siemens New MR Whole-Body Scanner Cleared

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FDA clears a Siemens Healthineers 510(k) for the MAGNETOM Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner.

Hold Lifted on Innate Lymphoma Trials

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FDA removes a partial clinical hold placed on Innate Pharma's Phase 2 TELLOMAK and Phase 1b PTCL trials of lacutamab in cutaneous ...

Consolidate Alternative Inspection Guidances: PhRMA

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PhRMA says FDA should consolidate its recent draft guidance on Remote Interactive Evaluations (RIE) of Drug Manufacturing and Bior...

ICH/EMA Viral Safety Guide Approved

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A European Medicines Agency committee has approved the International Council on Harmonizations Guidelines on viral safety evaluati...

Significant Opportunities for FDA Cloud Adoption: Report

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Eagle Hill consultants say FDA can profit from greater use of cloud technology if it can overcome some obstacles the consultants i...

OCE Working to Simplify Cancer Trials

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FDA cancer researchers say the Oncology Center of Excellence is working with stakeholders to simplify cancer clinical trials when ...

Pediatric Cancer Trial Subjects Appear Representative: Study

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FDA and National Institutes of Health researchers say the racial and ethnic representation in 20 years of pediatric cancer trials ...