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Maximizing Regulatory Review Efficiency: The Evolution of the FDA OCE RTOR Pilot
To promote the efficient review of oncology drug applications, the US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) launched the Real-Time Oncology Review (RTOR) pilot program in 2018. RTOR allows FDA to review individual sections of eCTD modules of a drug application for on...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer International Publishing
2022
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8744371/ https://www.ncbi.nlm.nih.gov/pubmed/35006588 http://dx.doi.org/10.1007/s43441-021-00371-z |