# Fast Track and RMAT designations

Source: https://onco.cc/terms/fast-track-rmat/  
OnCo record `fast-track-rmat` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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 Designations are frequently announced in press releases and can be rescinded; roughly a third of Fast Track drugs are eventually approved.

## Fields

- Kind: Term
- Last checked: 2026-09-09
- Also known as: 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

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Fast_track_(FDA)
- Wikipedia: https://en.wikipedia.org/wiki/Fast_track_(FDA)

## Connected records

- terms: [21st Century Cures Act](https://onco.cc/terms/21st-century-cures-act/), [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [BLA / NDA / MAA (marketing applications) and PDUFA dates](https://onco.cc/terms/bla-nda/), [Breakthrough Therapy / Priority Review / Priority Voucher](https://onco.cc/terms/breakthrough-designation/), [FDASIA 2012 and the origins of the expedited programmes](https://onco.cc/terms/fdasia-2012/), [ILAP (Innovative Licensing and Access Pathway)](https://onco.cc/terms/ilap/), [Japan conditional early approval and time-limited approval](https://onco.cc/terms/japan-conditional-early-approval/), [Orphan drug designation](https://onco.cc/terms/orphan-designation/), [Regulation (EC) No 726/2004: the EU centralised procedure](https://onco.cc/terms/eu-regulation-726-2004/), [Sakigake designation (Japan)](https://onco.cc/terms/sakigake/)
- fronts: [Drug Discovery Platforms](https://onco.cc/fronts/drug-discovery/)

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