{"entity":{"id":"fast-track-rmat","kind":"term","name":"Fast Track and RMAT designations","aka":["Fast Track","fast-track designation","Fast Track designation","RMAT","regenerative medicine advanced therapy","RMAT designation","PRIME","PRIority MEdicines","expedited programme","expedited program","expedited pathway","expedited review","expedited approval","fast track designations"],"tldr":"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.","summary":"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 Designations are frequently announced in press releases and can be rescinded; roughly a third of Fast Track drugs are eventually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.","asOf":"2026-09-09","wikipedia":"https://en.wikipedia.org/wiki/Fast_track_(FDA)","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Fast_track_(FDA)"}],"tags":[],"related":["breakthrough-designation","accelerated-approval","orphan-designation","bla-nda","fdasia-2012","21st-century-cures-act","sakigake","ilap","eu-regulation-726-2004"],"cancers":[],"sections":["drug-discovery"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Regulation & policy"},"route":"/terms/fast-track-rmat/","neighbours":{"term":[{"id":"21st-century-cures-act","kind":"term","name":"21st Century Cures Act","route":"/terms/21st-century-cures-act/"},{"id":"accelerated-approval","kind":"term","name":"Accelerated approval","route":"/terms/accelerated-approval/"},{"id":"bla-nda","kind":"term","name":"BLA / NDA / MAA (marketing applications) and PDUFA dates","route":"/terms/bla-nda/"},{"id":"breakthrough-designation","kind":"term","name":"Breakthrough Therapy / Priority Review / Priority Voucher","route":"/terms/breakthrough-designation/"},{"id":"fdasia-2012","kind":"term","name":"FDASIA 2012 and the origins of the expedited programmes","route":"/terms/fdasia-2012/"},{"id":"ilap","kind":"term","name":"ILAP (Innovative Licensing and Access Pathway)","route":"/terms/ilap/"},{"id":"japan-conditional-early-approval","kind":"term","name":"Japan conditional early approval and time-limited approval","route":"/terms/japan-conditional-early-approval/"},{"id":"orphan-designation","kind":"term","name":"Orphan drug designation","route":"/terms/orphan-designation/"},{"id":"eu-regulation-726-2004","kind":"term","name":"Regulation (EC) No 726/2004: the EU centralised procedure","route":"/terms/eu-regulation-726-2004/"},{"id":"sakigake","kind":"term","name":"Sakigake designation (Japan)","route":"/terms/sakigake/"}],"section":[{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}]}}