The experiment was done Monday in California on 44-year-old Brian Madeux. Through an IV, he received billions of copies of a corrective gene and a genetic tool to cut his DNA in a precise spot

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A new paper in the latest issue of Health Affairs is worth a look. “Drugs Cleared Through The FDA’s Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process“

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Review concludes drugs, costing £30k per patient, hailed as cure for potentially fatal liver disease may clear virus from blood, but there is no evidence they prevent harm or save lives

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World-first transplant to treat macular degeneration could augur rise of iPS cell banks

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As FDA investigated for years. A review of FDA records obtained by STAT under the Freedom of Information Act paint a far grimmer picture: Babies who were given Hyland’s teething products turned blue and died. Babies had repeated seizures. Babies became delirious. Babies were airlifted to the hospital

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President Trump’s vow to overhaul the Food and Drug Administration could bring major changes in policy, including steps to accelerate the process of approving new prescription drugs, setting up a clash with critics who say his push for deregulation might put consumers at risk

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Ethical review boards must focus on clinical promise as well as safety to hold the first tests of drugs in humans to a higher standard, say Jonathan Kimmelman and Carole Federico

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Ana Santos Rutschman: “As an FDA scholar at the Jaharis Health Law Institute at DePaul, I worry that faster regulatory review and approval might come at a cost. We may sacrifice safety and efficacy of drugs and devices approved under this new system”

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