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Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities
The United States Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) established the Real-Time Oncology Review (RTOR) pilot program in 2017 to streamline the review process for oncology drug applications with the applicant and the Agency agreeing upon a piecemeal strategy and tim...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8081281/ https://www.ncbi.nlm.nih.gov/pubmed/33913098 http://dx.doi.org/10.1007/s43441-021-00296-7 |