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...

Descripción completa

Detalles Bibliográficos
Autores principales: Gao, Ya Grace, Roberts, Samantha, Guy, Allison
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Analytical Report
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

Internet

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

Ejemplares similares