FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies Source: FDA Press Releases

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FDA Halts New Clinical Trials That Export Americans’ Cells to Foreign Labs in Hostile Countries for Genetic Engineering

FDA Halts New Clinical Trials That Export Americans’ Cells to Foreign Labs in Hostile Countries for Genetic Engineering Source: FDA Press Releases

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FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests

The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. Source: FDA Press Releases

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FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People

The U.S. Food and Drug Administration (FDA) today launched Elsa, a generative Artificial Intelligence (AI) tool designed to help employees—from scientific reviewers to investigators—work more efficiently. Source: FDA Press Releases

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FDA Takes Action to Address Data Integrity Concerns with Two Chinese Third-Party Testing Firms

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health has issued letters to two third-party medical device testing firms in China. Source: FDA Press Releases

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FDA and CBP Seize Nearly $34 Million Worth of Illegal E-Cigarettes During Joint Operation

The U.S. Food and Drug Administration (FDA) today announced the seizure of nearly two million units of unauthorized e-cigarette products in Chicago, with an estimated retail value of $33.8 million.…

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