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Requirements and Study Designs for U.S. Regulatory Approval of Influenza Home Tests
Home testing for infectious disease has come to the forefront during the COVID-19 pandemic. There is now considerable commercial interest in developing complete home tests for a variety of viral and bacterial pathogens. However, the regulatory science around home infectious disease test approval and...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
American Society for Microbiology
2022
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9116184/ https://www.ncbi.nlm.nih.gov/pubmed/34911365 http://dx.doi.org/10.1128/jcm.01884-21 |