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The New S7B/E14 Question and Answer Draft Guidance for Industry: Contents and Commentary
In August 2020, the International Council on Harmonisation (ICH) released a new draft document, which for the first time combined nonclinical (S7B) and clinical (E14) Questions and Answers (Q&As) into 1 document. FDA describes the revision as a “value proposition”: if the human ether‐à‐go‐go ass...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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John Wiley and Sons Inc.
2021
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9290990/ https://www.ncbi.nlm.nih.gov/pubmed/33896027 http://dx.doi.org/10.1002/jcph.1880 |