Tag: FDA
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Infographic – Mediocre ClinicalTrials.gov Report Rates
New data show most sponsors of clinical trials are not reporting their results on time to a U.S. government web site as required by law.
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Artificial Pancreas System Cleared by FDA
A system for automatically measuring blood glucose levels and dispensing insulin for people with type 1 diabetes is authorized by the Food and Drug Administration.
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FDA Blocks Monthly HIV Drug Combo
The U.S. Food and Drug Administration rejected a combination of experimental and existing drugs given once a month to treat HIV.
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Bioprinting Ear Tissue Tagged Rare Disease Treatment
A company developing 3-D printed outer ear tissue received a rare pediatric disease designation on its treatment designed for children.
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Retail Clinics Offer A.I.-Enabled Eye Diagnostics
A chain of primary care clinics in grocery stores is adding diagnostics using artificial intelligence to detect an eye disorder resulting from type 2 diabetes.
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Safety Reports Analyzed with A.I. to Reduce Medical Errors
Research is underway to write algorithms for analyzing free text and other unstructured data in safety report databases to reduce medical errors.
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Partnership to Assess Digital Gut Disease Treatments
A digital therapeutics enterprise and a company developing therapies for intestinal disorders are evaluating the potential of digital treatments for gut diseases.
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FDA – New Processes, Incentives Needed for Drug Shortages
A report from the Food and Drug Administration identifies the causes of recent shortages of some drugs, and calls for new processes and incentives to prevent future shortages.
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FDA Tags Biofilm Disruption Device as Breakthrough
A system using an electric current to break up bacterial communities on orthopedic implants received a breakthrough-device designation from the Food and Drug Administration.
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Real-World Evidence Assessed for Cancer Drug Trials
Two medical technology companies are evaluating real-world evidence from patients to simulate randomized clinical trials for testing new cancer treatments.