• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Long Term Outcome Goals - FY 2006 - Images Long Description

<< Return to FY 2006 Long Term Outcome Goals

 

The chart entitled, "Time for 50% of Priority NME/BLA Receipt Cohort to be Approved (in months)."

The X-axis is by fiscal year from 1993 through 2002.

The Y-axis is by months for 50% of priority NME/BLA Receipt Cohort to be approved ranging from 0.0 to 36.0.

The chart shows two trend lines:

  • Priority BLA/NMEs Total Approval Time; and,
  • Priority BLA/NMEs Total FDA Time.

In 1993, 12.1 months was the priority BLA/NMEs Total Approval Time and 12.1 months was the priority BLA/NMEs Total FDA Time.

In 1994, 18.7 months was the priority BLA/NMEs Total Approval Time and 16.4 months was the priority BLA/NMEs Total FDA Time.

In 1995, 12.3 months was the priority BLA/NMEs Total Approval Time and 12.3 months was the priority BLA/NMEs Total FDA Time.

In 1996, 8.6 months was the priority BLA/NMEs Total Approval Time and 8.6 months was the priority BLA/NMEs Total FDA Time.

In 1997, 8.7 months was the priority BLA/NMEs Total Approval Time and 7.8 months was the priority BLA/NMEs Total FDA Time.

In 1998, 6.4 months was the priority BLA/NMEs Total Approval Time and 6.3 months was the priority BLA/NMEs Total FDA Time.

In 1999, 6.0 months was the priority BLA/NMEs Total Approval Time and 6.0 months was the priority BLA/NMEs Total FDA Time.

In 2000, 8.3 months was the priority BLA/NMEs Total Approval Time and 8.1 months was the priority BLA/NMEs Total FDA Time.

In 2001, 15.6 months was the priority BLA/NMEs Total Approval Time and 12.1 months was the priority BLA/NMEs Total FDA Time.

In 2002, 9.0 months was the priority BLA/NMEs Total Approval Time and 8.0 months was the priority BLA/NMEs Total FDA Time.

 


 

The chart entitled, "Time for 50% of Standard NME/BLA Receipt Cohort to be Approved (in months)."

The X-axis is by fiscal year from 1993 through 2001.

The Y-axis is by months for 50% of standard NME/BLA Receipt Cohort to be approved ranging from 0.0 to 36.0.

The chart shows two trend lines:

  • Standard BLA/NMEs Total Approval Time; and,
  • Standard BLA/NMEs Total FDA Time.

In 1993, 35.0 months was the standard BLA/NMEs Total Approval Time and 30.8 months was the standard BLA/NMEs Total FDA Time.

In 1994, 16.3 months was the standard BLA/NMEs Total Approval Time and 15.0 months was the standard BLA/NMEs Total FDA Time.

In 1995, 17.9 months was the standard BLA/NMEs Total Approval Time and 17.0 months was the standard BLA/NMEs Total FDA Time.

In 1996, 15.0 months was the standard BLA/NMEs Total Approval Time and 15.0 months was the standard BLA/NMEs Total FDA Time.

In 1997, 15.9 months was the standard BLA/NMEs Total Approval Time and 15.0 months was the standard BLA/NMEs Total FDA Time.

In 1998, 21.5 months was the standard BLA/NMEs Total Approval Time and 18.1 months was the standard BLA/NMEs Total FDA Time.

In 1999, 23.8 months was the standard BLA/NMEs Total Approval Time and 21.0 months was the standard BLA/NMEs Total FDA Time.

In 2000, 28.8 months was the standard BLA/NMEs Total Approval Time and 18.6 months was the standard BLA/NMEs Total FDA Time.

In 2001, 30.1 months was the standard BLA/NMEs Total Approval Time and 17.1 months was the standard BLA/NMEs Total FDA Time.

The data points for 2001 are projected and are indicated on the chart with dashed lines.

 

<< Return to FY 2006 Long Term Outcome Goals