Navigating regulatory pathways for translation of biologic cartilage repair products
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DOI: 10.1126/scitranslmed.abp8163
Abstract: Long-term clinical repair of articular cartilage remains elusive despite advances in cartilage tissue engineering. Only one cartilage repair therapy classified as a “cellular and gene therapy product” has obtained Food and Drug Administration (FDA) approval… read more here.
Keywords: therapy; navigating regulatory; cartilage repair; translation ... See more keywords
562-P: Navigating Regulatory Challenges for Diabetes Devices—A Comparative Analysis of EU and U.S. Frameworks
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DOI: 10.2337/db25-562-p
Abstract: Introduction and Objective: The growing prevalence of diabetes presents major public health and economic challenges, driving the need for innovative medical devices. However, navigating the regulatory frameworks of the European Union (EU) and the United… read more here.
Keywords: medical devices; 562 navigating; diabetes devices; challenges diabetes ... See more keywords