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. 2022 Mar;56(2):212-219.
doi: 10.1007/s43441-021-00371-z. Epub 2022 Jan 10.

Maximizing Regulatory Review Efficiency: The Evolution of the FDA OCE RTOR Pilot

Ya Grace Gao  1   2 , Samantha Roberts  3 , Allison Guy  4
Affiliations

Maximizing Regulatory Review Efficiency: The Evolution of the FDA OCE RTOR Pilot

Ya Grace Gao et al. Ther Innov Regul Sci. 2022 Mar.

Abstract

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 oncology drugs in contrast to requiring the applicant to submit complete modules or the complete application before review is initiated. Initially, the program accepted only supplemental applications with simple study designs and easily interpretable endpoints, but the scope has since been expanded to include applications for New Molecular Entities (NME), and other applications with more complex features. Though many applicants experience faster approvals under RTOR, it is difficult to isolate the effect of the RTOR program on review timelines as its contribution is masked by other expedited programs like priority review and breakthrough therapy designation (BTD). This article discusses the expanded scope of RTOR, its interplay with other OCE initiatives to modernize regulatory review, summarizes Genentech's experiences in planning RTOR submissions from February 2019 to July 2021, and provides considerations for the future of the program.

Keywords: Expedited review program; FDA OCE pilot programs; Oncology center of excellence; Oncology drug review; Real-time oncology review; US food and drug administration.

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Conflict of interest statement

On behalf of all authors, the corresponding author states that there is no conflict of interest.

Figures

Figure 1
Figure 1
FDA OCE Programs to Modernize Regulatory Review.
See this image and copyright information in PMC

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