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Regulatory


FDA Makes Recommendations for COVID-19 Variants

FDA Makes Recommendations for COVID-19 Variants

The U.S. Food and Drug Administration (FDA) has revealed recommendations for drug developers and diagnostic test makers to address the efficacy and overall performance of their products in consideration of the COVID-19 variants. The updates in recommendations are...
FDA Approves First Ever 3D-Printed Bone Replacement

FDA Approves First Ever 3D-Printed Bone Replacement

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has granted approval for the first customized 3D-printed bone replacement. The device, named Patient Specific Talus Spacer, is the only 3D-printed device in the world, and...