![]() Participation in RTOR does not guarantee approval for an application nor is it intended to enable early action prior to the Prescription Drug User Fee Act (PDUFA) date. In December 2018, the program was expanded to include review of original drug applications. As one of several initiatives led by OCE, the Real-Time Oncology Review (RTOR) program was initially piloted in February 2018 to streamline and improve efficiency of the review process for supplemental applications in oncology. The United States Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) was first established in 2017 with the goal of achieving patient-centered regulatory decision-making through innovation and collaboration . The full impact of RTOR on applications remains undetermined as the number of approved applications that have participated in the pilot program is still relatively small. However, the optional biweekly teleconferences increased communication and collaboration between the applicant and the FDA. The time savings is not guaranteed as other parts of the review may influence the overall timeline. ![]() The FDA approved 3 out of the 4 applications approximately three to four months before the PDUFA goal date. These four case studies demonstrated an individualized RTOR process reflecting the program’s pilot status. Initial marketing applications were further reviewed to identify any potential advantages or limitations from participation in the pilot program. Publicly available databases and documents were searched for all RTOR applications, which revealed a total of 28 approved applications that participated from February 2018 to August 2020. Applicants must also meet certain criteria regarding the clinical trial design and development program to be eligible for RTOR. Participation requires careful planning of time and resources due to the multiple submissions and interactions with the FDA. The Prescription Drug User Fee Act (PDUFA) review clock does not officially start until the final component is submitted. ![]() 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.
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