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Lessons from Canada’s notice of compliance with conditions policy for the life-cycle regulation of drugs
Innovative health technologies are not well regulated under current pathways, leading regulators to adopt contextual, life-cycle regulatory models, which authorize drugs based on earlier clinical evidence subject to the conduct of post-market trials that confirm clinical benefit and safety. In this...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Oxford University Press
2023
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10101551/ https://www.ncbi.nlm.nih.gov/pubmed/37064046 http://dx.doi.org/10.1093/jlb/lsad008 |