I thought it a good idea to take a look back at the Fast Track status and get an idea of what the trends have been in this all important category. Though the chart below is copied from the CDER Web page on CDER Response to Fast Track Designation, it also embraces actions on biologic products.
Fast track status is "designed to facilitate the development and expedite the review of new drugs or biologics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs." For starter’s here is the track record so far for this year to a request for fast track designation in 2006 from the CDER Web page re same:
|Number Submitted||Goal||Within Goal||Overdue|
|Fast Track Requests||86||60 days||49||10||15||74||86%||8||2||2||12||14%|
This year, there have been a total of 86 submissions. Of those a total of 57 have been granted, with 12 denied and 17 still pending. In other words, 66% of those who applied for Fast Track this year got it, while 14% failed and 20% are waiting for an answer.
As noted in the chart above, the agency aims to have an answer within 60 days of an application for Fast Track, but this year has met that target only 86% of the time. Still, for those who had to wait longer, their approval rating was higher.
For those interested, there is a Guidance on Fast Track at the FDA Web Site. Later, we’ll compare this year to other years to see how the agency has been faring.