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# Breakthrough Drugs See Shorter Development Times: Analysis
- URL: https://www.fdaweb.com/breakthrough-drugs-see-shorter-development-times-analysis/
- Published: 2016-03-14T12:00:00.000Z
- Updated: 2026-09-15T02:43:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135062

> Cancer therapies are reaping rewards under FDA’s breakthrough therapy program. According to a [new analysis](http://www.nature.com/nrd/journal/v15/n3/full/nrd.2016.19.html?ref=fdaweb.com) released by Friends of Cancer Research (FOCR), drugs with breakthrough designations gained approval more quickly than those without the designation and they experienced faster pre-market development and review times. “We also found that considerably more breakthrough-designated drugs were approved via the accelerated approval pathway than non-designated drugs, and that breakthrough-designated drugs were more often approved on the basis of Phase 1 or Phase 2 trials,” FOCR says. “We also conclude that, owing to the large number of accelerated approvals among breakthrough-designated drugs, the FDA is more willing to take measured risks in approving drugs that show early evidence of substantial improvement over available therapy.”  
>  
> Breakthrough drugs typically were approved about three months before their user fee goal dates compared with those without the designation,” the group says. “Pre-market development time, calculated as the number of years from submission of an investigational new drug application (IND) to submission of a new drug application (NDA) or biologics license application (BLA), was considerably shorter among approved breakthrough-designated drugs (median 5.2 years) than non-designated drugs (median 7.4 years), a difference of 2.2 years,” it says.