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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...

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Detalles Bibliográficos
Autores principales: Feng, Catherine, Virparia, Riddhi, Mui, Eric T.-K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
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