Fast Track and RMAT designations
Two of the FDA's expedited programmes: Fast Track gives drugs for serious unmet needs more frequent FDA meetings and rolling review; RMAT is the equivalent for cell and gene therapies. Neither guarantees approval or changes the evidence standard.
Fast Track (1997) is granted on preclinical or early clinical data and is the most common designation; Breakthrough Therapy (2012) requires preliminary evidence of substantial improvement and brings intensive guidance; RMAT (2016, 21st Century Cures Act) applies breakthrough-like benefits to cell therapies, gene therapies and tissue-engineered products, including CAR-T; Priority Review shortens the review clock; Accelerated Approval permits surrogate endpoints. The EMA's PRIME and Japan's Sakigake are counterparts. Designations are frequently announced in press releases and can be rescinded; roughly a third of Fast Track drugs are eventually approved.
Pages like this
not linked directly; found by shared links- TermReal-Time Oncology Review (RTOR) and Assessment Aid
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Breakthrough Therapy / Priority Review / Priority Voucher, Accelerated approval.
- TermLabel, indication and label expansion
Shares Orphan drug designation, BLA / NDA / MAA (marketing applications) and PDUFA dates, 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.
- InstitutionFDA Oncology Center of Excellence
Shares Breakthrough Therapy / Priority Review / Priority Voucher, Accelerated approval.