Medicare Still Won’t Pay for Alzheimer’s Drugs without Confirmatory Data
PharmTech Talk | Pharmaceutical Technology
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11M ago
Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval ..read more
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FDA Proposes Streamlined Medication Handouts
PharmTech Talk | Pharmaceutical Technology
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1y ago
FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products ..read more
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FDA Eyes Advisory Committee Reform to Enhance Credibility
PharmTech Talk | Pharmaceutical Technology
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1y ago
Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change ..read more
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FDA Is Hiring!
PharmTech Talk | Pharmaceutical Technology
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1y ago
The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies ..read more
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Court Ruling Leaves FDA Authority in Limbo
PharmTech Talk | Pharmaceutical Technology
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1y ago
The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process ..read more
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FDA Regulatory Authority Under Attack
PharmTech Talk | Pharmaceutical Technology
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1y ago
Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides ..read more
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FDA Backs Randomized Trials for Accelerated Drug Approval
PharmTech Talk | Pharmaceutical Technology
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1y ago
FDA aims to address mounting criticisms of its accelerated approval pathway ..read more
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Makena Saga Shows How Hard It Is to Remove Unproven Drug from Market
PharmTech Talk | Pharmaceutical Technology
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1y ago
Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy ..read more
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Congress Probes PBM Link to Higher Drug Prices
PharmTech Talk | Pharmaceutical Technology
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1y ago
Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines ..read more
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IRBs Need More Monitoring
PharmTech Talk | Pharmaceutical Technology
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1y ago
GAO calls for more oversight of institutional review boards in clinical trials ..read more
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