Navigating the Global Regulatory Landscape for Exosome-Based Therapeutics: Challenges, Strategies, and Future Directions
Extracellular vesicle (EV)-based therapies have attracted considerable attention as a novel class of biologics with broad clinical potential. However, their clinical translation is impeded by the fragmented and rapidly evolving regulatory landscape, with significant disparities between the United States, European Union, and key Asian jurisdictions. In this review, we systematically analyze regional guidelines and strategic frameworks governing EV therapeutics, emphasizing critical hurdles in qua
Record details
Published: 30 July 2025
Source: OpenAlex
Category: Research
Topics: Regulation · Healthcare · Biotech
Retrieved: 14 July 2026
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ethics.ai (30 July 2025), “Navigating the Global Regulatory Landscape for Exosome-Based Therapeutics: Challenges, Strategies, and Future Directions,” evidence record 9730, https://ethics.ai/record/9730 (originally published by OpenAlex).
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