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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 ...

Breakthrough Status for Cancer Detector

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FDA grants Geneseeq a breakthrough device designation for its multi-cancer early detection device, CanScan.

Public Citizen Announces Death of Sidney Wolfe

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Public Citizen mourns the 1/1 death of Health Research Group founder Sidney Wolfe.

3 Observations in Dr. Reddys Lab Inspection

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FDA releases the FDA-483 issued following an inspection at the Dr. Reddys drug testing establishment in Telangana, India.

Update on Drager Neonatal Incubators

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An FDA safety update says it has determined that new neonatal incubators by Drager (also known as Draeger) do not need to be run f...

Agios Mitapivat Study Meets Endpoint

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Agios Pharmaceuticals reports that the Phase 3 ENERGIZE study of Pyrukynd (mitapivat) in adults with non-transfusion-dependent alp...

FDA 2023 Novel Drug Approvals Up

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FDA says CDER approved 55 new drugs in 2023, almost 50% more than in 2022.

FDA Guidance Best Practices Plan

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FDA asks for comments on a report on agency best practices for guidance documents.