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Human Drugs

Consolidate Alternative Inspection Guidances: PhRMA

PhRMA says FDA should consolidate its recent draft guidance on Remote Interactive Evaluations (RIE) of Drug Manufacturing and Bioresearch Monitoring F...

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Human Drugs

ICH/EMA Viral Safety Guide Approved

A European Medicines Agency committee has approved the International Council on Harmonizations Guidelines on viral safety evaluation of certain produc...

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Human Drugs

Significant Opportunities for FDA Cloud Adoption: Report

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

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Human Drugs

OCE Working to Simplify Cancer Trials

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

Human Drugs

Pediatric Cancer Trial Subjects Appear Representative: Study

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

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Human Drugs

Breakthrough Status for Cancer Detector

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

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FDA General

Public Citizen Announces Death of Sidney Wolfe

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

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Human Drugs

3 Observations in Dr. Reddys Lab Inspection

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

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Medical Devices

Update on Drager Neonatal Incubators

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

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Human Drugs

Agios Mitapivat Study Meets Endpoint

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