Category: Regulations
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Biotech Group Blasts Reproductive Drug Ruling
A biotechnology industry group calls Friday’s ruling in a Federal district court to suspend approval of the drug mifepristone “an assault on science.”
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Trial Okayed for Glaucoma Treatment Implant
A developer of treatments for eye diseases says it received clearance from FDA to begin a clinical trial of a sustained-release implant therapy for glaucoma.
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PCORI Funds Personal Dialysis Model Assessment
A team from an academic medical center and research institute are evaluating a personalized dialysis model for people with kidney disease, but with still some kidney functions.
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Panel: A.I. Regulation Needed, But Long Way Off
A panel of data scientists at a professional meeting says artificial intelligence needs more rigorous oversight, but many questions remain on who and how to do the regulating.
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Over-the-Counter Naloxone Receiving Faster FDA Review
The opioid overdose drug naloxone in nasal spray form is receiving priority review from the Food and Drug Administration as an over-the-counter drug.
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FDA Clears AI Heart Failure Detection System
The Food and Drug Administration authorized for marketing an algorithm-driven medical device for diagnosing a common, but difficult to detect, type of heart failure.
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FDA Clears Digital Health Monitoring System
A developer of remote health tracking technology says the Food and Drug Administration cleared its continuous patient monitoring system for clinical use.
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Company to Boost Orphan Drugs in Europe
A start-up enterprise seeks to make drugs for treating rare diseases more readily available to physicians and patients in Europe.
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RSV Nose Drops Vaccine Gets FDA Fast Track Tag
A vaccine designed from engineered live viruses and taken as nose drops to prevent respiratory syncytial virus received a Food and Drug Administration fast-track designation.
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FDA Clearance Requested for Behavioral Diabetes Therapy
A digital health company is asking for FDA authorization to market a mobile app that helps treat type 2 diabetes with cognitive behavioral therapy.