Category: Regulations
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Govt. Shutdown Disrupts U.S. Science
Several agencies that run or finance labs are closed, due to the lapse of funding for about a quarter of federal departments that began on 22 December.
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FDA Clears Inhaled Parkinson’s Drug
A drug administered as an inhaled powder to supplement a common treatment for Parkinson’s disease received approval for marketing from the Food and Drug Administration.
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CDC Finds 12 People Sickened by Stem Cell Provider
Centers for Disease Control and Prevention issued a report on a provider of stem cell therapies indicating 12 people in 3 states were infected with bacteria from that company’s treatments.
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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.