Tag: FDA
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FDA Warns Cord Blood-Stem Cell Company
Food and Drug Administration recently warned GeneTech Inc. that its unauthorized stem cell regenerative medicine products, may be causing serious blood infections.
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Validation Scheme Proposed for Medical Algorithms
A law school professor urges developers, users, and regulators of machine learning in medicine to validate the algorithms that represent their underlying decision-making processes.
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FDA Clears Mobile App for Opioid Use Disorder
The Food and Drug Administration authorized a mobile app, when prescribed by clinicians for patients with opioid use disorder in outpatient treatment programs.
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Report – 289 Cell and Gene Therapies in Development
A report by a pharmaceutical industry organization says nearly 300 new therapies that transfer live cells or genes as treatments for disease are in clinical trials or being reviewed by Food and Drug Administration.
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FDA Identifies Database to Evaluate Precision Diagnostics
The Food and Drug Administration identified a public database of genomics and diseases as a resource to assess new diagnostics tests using genetic data for precision medicine.
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Trials OK’d for Inherited Eye Disease Therapy with Crispr
The company developing a treatment for a rare inherited eye disease using the genome editing technique Crispr received authorization from the Food and Drug Administration to begin clinical trials.
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FDA Approves Biomarker-Targeting Cancer Drug
The Food and Drug Administration yesterday approved a treatment for solid tumor cancers that focuses on specific cancer-causing genetic conditions rather than location of the cancer in the body.
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Trial Shows Treatment Prevents Peanut Allergy Reactions
Final results from a clinical trial show a preventive treatment desensitizes children and adolescents with peanut allergies against reaction-causing proteins in peanuts for one year.
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Survey Shows Sharp Rise in Teen E-Cigarette Use
New data from a continuing survey of smoking among school-age children shows large increases in electronic cigarette use in high school and middle school children in just the past year.
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FDA Updating Expanded Access to Investigational Drugs, Devices
The Food and Drug Administration says it’s streamlining policies for making drugs and medical devices in clinical trials or under review available for people in the U.S. with life-threatening conditions.