Statement from Commissioner Makary:100 Days of Embracing Gold-Standard Science, Transparency and Common Sense Source: FDA Press Releases

The FDA today published more than 200 decision letters, known as complete response letters (CRLs). Source: FDA Press Releases

The U.S. Food and Drug Administration encourages industry leaders involved in manufacturing and distribution of infant formula, baby foods, and foods intended for children to streamline and enhance product recall…

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

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

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

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

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

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.…

The U.S. Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its…