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Evaluating integration in collaborative cross-disciplinary FDA new drug reviews using an input-process-output model
BACKGROUND/OBJECTIVES: The US Food and Drug Administration (FDA) is responsible for assessing safety (risks) and effectiveness (benefits) of new drug products using the data provided in a Sponsor’s new drug product marketing application before they can be marketed. The FDA forms cross-disciplinary r...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Cambridge University Press
2021
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8727715/ https://www.ncbi.nlm.nih.gov/pubmed/35047211 http://dx.doi.org/10.1017/cts.2021.861 |