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# Breakthrough, Fast Track Programs Cut Approval Times: Study
- URL: https://www.fdaweb.com/breakthrough-fast-track-programs-cut-approval-times-study/
- Published: 2017-12-05T12:00:00.000Z
- Updated: 2026-09-14T23:05:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140273

The *Los Angeles Times* [says](http://www.latimes.com/science/sciencenow/la-sci-sn-fda-expedited-drugs-20171205-story.html?ref=fdaweb.com) that researchers who [evaluated](https://jamanetwork.com/journals/jama/article-abstract/2664989?ref=fdaweb.com) four FDA programs designed to speed drug approval found that 105 drugs and biologics approved between 1/2012 and 12/2016 went through the approval process with one of four designations intended to speed the path to approval, while 69 medications received no such designation. Drugs in one of the four accelerated programs took between 5.1 and 10.1 years to get through the process, with a midpoint of 7.1 years. Those without any designation needed 6.5 to 10 years to go from the start of human trials to FDA approval, with a midpoint of eight years.

The faster speeds were largely attributable to two programs — breakthrough designation and fast track — the researchers found. In contrast, they said, the Accelerated Approval program and Priority Review program did not shorten the time needed to get from human trials to agency approval.

The *Times* quotes University of California San Francisco health economist **Adams Dudley** that the new research underscores that when it comes to shortening drug development times, one key factor that appears to make a difference is intensive attention from FDA evaluators. But providing such attention takes a commitment to staffing for an agency facing a significant budget cut and the likelihood of state reductions, the article says.