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America Must Address Early Clinical Development | FDA

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The .gov means it’s official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. An update on the Cyclospora outbreak available here. FDA VOICES By: Karim Mikhail, B. Pharm, MSc, Acting Director of the Center for Biologics Evaluation and Research America is losing ground on clinical trials. Phase 1 trials that may take up to two years to complete here in the United States are completed in nine months in China, threatening America’s leadership in scientific innovation. To combat this, President Trump and Secretary Kennedy have directed the U. S. Food and Drug Administration to use every tool at its disposal to reverse this trend. The consequences are broad. Patients lose access to investigational therapies and may have to travel abroad to

Image By: Karim Mikhail, B. Pharm, MSc, Acting Director of the Center for Biologics Evaluation and Research The Problem: America is at Risk of Being Left Behind America is losing ground on clinical trials. Phase 1 trials that may take up to two years to complete here in the United States are completed in nine months in China, threatening America’s leadership in scientific innovation. To combat this, President Trump and Secretary Kennedy have directed the U. S. Food and Drug Administration to use every tool at its disposal to reverse this trend. The consequences are broad. Patients lose…

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