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Use of real-world evidence to support regulatory decisions on medical devices in China and a unique opportunity to gain accelerated approval in “Boao Lecheng Pilot Zone”
This article aims to summarize the development and challenges of real-world data (RWD) and real-world evidence (RWE) in China and introduce a unique opportunity for medical devices to gain accelerated regulatory approval in China by utilizing RWE generated in a free trade pilot zone “Boao Lecheng” i...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BioMed Central
2023
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9850538/ https://www.ncbi.nlm.nih.gov/pubmed/36653783 http://dx.doi.org/10.1186/s12962-022-00412-w |