The Regulatory Tightrope: Navigating US and EU Approval Pathways

أضاف وظيفة جديدة أخرى

2025-12-08 17:10:21 - ترجمة -

The greatest single barrier to the widespread commercialization and adoption of phage therapy in Western markets is the lack of standardized, clear regulatory pathways in the United States (FDA) and the European Union (EMA). Because phages are unique, self-replicating biological agents, they do not fit easily into the established frameworks designed for chemical drugs or simple biologics. The...

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