# FDA Fast Track?

**URL:** https://forum.livingwithataxia.org/t/fda-fast-track/3047
**Category:** General
**Created:** [March 8, 2016, 8:43pm UTC](https://forum.livingwithataxia.org/t/fda-fast-track/3047 "2016-03-08T20:43:51Z")
**Posts on this page:** 1
**Page:** 1

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### Author: ![sunny8088](https://yyz1.discourse-cdn.com/flex027/user_avatar/forum.livingwithataxia.org/sunny8088/32/1698_2.png) [@sunny8088](https://forum.livingwithataxia.org/u/sunny8088)
#### Post date: [March 8, 2016, 8:43pm UTC](https://forum.livingwithataxia.org/t/fda-fast-track/3047/1 "2016-03-08T20:43:51Z")

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Why the FDA approval process is so slow for ACTIMMUNE even after it received the fast track status. We know we are on a path on 'Use it or Loose it' , delay in approval of drug can be devastating for many of us.

Regards

Horizon Pharma plc Receives FDA Fast Track Designation for ACTIMMUNE(R) in the Treatment of Friedreich's Ataxia

[http://ir.horizon-pharma.com/releasedetail.cfm?releaseid=905891](http://ir.horizon-pharma.com/releasedetail.cfm?releaseid=905891)

Source: [http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm279676.htm](http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm279676.htm)

A: The 1992 Prescription Drug User Fee Act (PDUFA) established a two-tiered system – _Standard Review_ and_Priority Review_.

_Standard Review_ is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a 10 month goal for a standard review.

_Priority Review_ designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months.