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The Real-Time Oncology Review (RTOR) Pilot Program for New Molecular Entities Approvals
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- The Real-Time Oncology Review (RTOR) Pilot Program for New Molecular Entities Approvals
- FDA Guidance for Human Gene Therapy for Hemophilia A & B
- Patient Centricity in Clinical Trials
- How to improve your chances of getting FDA approval
- Biomarker Applications in Drug Discovery and Development
- Risk-based monitoring in clinical research
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Biomarkers as drug development tools: discovery, validation, qualification and use
[/vc_column_text][vc_column_text]The Real-Time Oncology Review (RTOR) pilot programme was developed by the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) in 2017 to expedite the review process for oncology drug applications by agreeing on a single approach and timetable for module components. The review clock for the Prescription Drug User Fee Act (PDUFA) does not officially begin until the final element is submitted. Due to the various filings and interactions with the FDA, participation necessitates careful time and resource preparation. To be eligible for R.T., applicants must also satisfy specific clinical trial design and development requirements. All RTOR applications were found using publicly available databases and documents, revealing 28 approved applications that took place between February 2018 and August 2020. Initial marketing applications were looked at again to see any possible benefits or drawbacks to participating in the pilot programme. These four case studies each showed a unique RTOR methodology that reflected the program’s pilot stage. Three of the four applications were approved by the FDA three to four months before the PDUFA deadline. Because other aspects of the evaluation may impact the total timeframe, the time savings cannot be guaranteed. The FDA and the applicant could communicate and collaborate more effectively because of the optional biweekly teleconferences. Because the number of accepted applications that have participated in the pilot programme is still limited, the real impact of RTOR on applications is still unknown.[/vc_column_text][vc_column_text]
References
Feng, Catherine, Riddhi Virparia, and Eric T-K. Mui. “Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities.” Therapeutic Innovation & regulatory science (2021): 1-8.[/vc_column_text][/vc_column][/vc_row]
