How often does FDA use expedited regulatory pathway for oncology drugs?

Healthcare Economist September 1, 2025
Jason Shafrin

FDA uses expedited regulatory pathways (ERPs) in order to accelerate the availability of drugs and diagnostic tests for severe conditions that have unmet medical needs. How often is this process used and has this changed over time? A recent paper by Horn et al. (2025) provides the answer as applied to colorectal cancer (CRC) drugs. First, they provide a summary of the legislative changes that allowed for FDA’s use of ERPs.

Under ERPs, the FDA reduces review time and allows for more frequent developer interactions. The first ERP, Priority Review, started in 1992 under the Prescription Drug User Fee Act (PDUFA). PDUFA allowed the FDA to collect fees from drug sponsors to reduce regulatory review time, more than tripling...

Today's Sponsors

Today's Sponsor