Real-Time Oncology Review (RTOR) and Assessment Aid
FDA processes that let reviewers start on trial data before the full application is filed, speeding approvals by months.
RTOR (2018) allows early submission of top-line efficacy and safety data; the Assessment Aid is a sponsor-prepared template that streamlines review. Together with priority review and breakthrough designation, they explain why many oncology approvals arrive well before PDUFA dates.
Pages like this
not linked directly; found by shared links- TermFast Track and RMAT designations
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Breakthrough Therapy / Priority Review / Priority Voucher, Accelerated approval.
- TermOrphan drug
Shares Breakthrough Therapy / Priority Review / Priority Voucher, Accelerated approval.
- IdeaTransferable priority vouchers for first-in-class drugs, with price conditions
Shares Breakthrough Therapy / Priority Review / Priority Voucher, Accelerated approval.
- TermLabel, indication and label expansion
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Accelerated approval.
- InstitutionFDA Oncology Center of Excellence
Shares Breakthrough Therapy / Priority Review / Priority Voucher, Accelerated approval.