
FDA Removes Key Barrier to Real-World Evidence for Drugs and Medical Devices
The U.S. Food and Drug Administration has announced a change to how it evaluates real world evidence in regulatory reviews. In
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The U.S. Food and Drug Administration has announced a change to how it evaluates real world evidence in regulatory reviews. In
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The U.S. Food and Drug Administration has announced new actions aimed at improving recall effectiveness following an investigation into an
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Members of the U.S. House of Representatives have introduced the Childhood Diabetes Reduction Act of 2025, a bill that would
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Businesses in Canada have long raised concerns about red tape in Health Canada regulations, from outdated rules to lengthy approval
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FDA unannounced inspections are no longer limited to U.S. facilities. The U.S. Food and Drug Administration (FDA) recently announced an
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If your team handles drug product submissions in Canada, there’s a recent update from Health Canada you might want
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Are you a small or medium-sized business (SME) planning to launch a novel food in the European Union? If so,
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