Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities.

ABSTRACT: 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 timeline for module components. The Prescription Drug User Fee Act (PDUFA) review clock does not officially start until the final component is submitted. Participation requires careful planning of time and resources due to the multiple submissions and interactions with the FDA. Applicants must also meet certain criteria regarding the clinical trial design and development program to be eligible for RTOR. Publicly available databases (Drugs@FDA) and documents were searched for all RTOR applications,

SUBMITTER: Feng C 

PROVIDER: S-EPMC8081281 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature