Category: Regulations
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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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Analysis – Health Care Law Ruled Unconstitutional
Adler and Gluck call the action, “a shocking legal ruling.” In addition, the authors characterize the decision as, “an exercise of raw judicial power.”
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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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Infographic – U.S., Canada Top National Carbon Footprints
The U.S. and Canada each emit nearly 15 metric tons of CO2 per person, leading the list of top national polluters.
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Post-Surgical Opioid Prescriptions Safely Cut
A cancer center reduced its opioid pain prescriptions for surgery for a year, without patients reporting more pain, complications, or requests for more pills.
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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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The Resurgence of “They Did Surgery on a Grape”
If a machine can carry out a delicate surgical task on something as vulnerable and soft as a grape, we begin to wonder whether such machines could be put to work on people too.
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Recap – Editas Medicine Advances Crispr Therapy
Editas Medicine received the go-ahead to conduct a clinical trial using the genome editing technique Crispr.
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Infographic – HIV Infections Growing in Eastern Europe
While much attention is focused on the continuing AIDS and HIV crisis in Africa, countries in Eastern Europe are also facing growing numbers of HIV infections.