Approval Times for New Drug Applications

This chart shows the median time in months for approval of Standard Applications compared with Priority Applications.

The approval time for Standard Applications in 1994 was a little under 24 months and gradually fell to a low of 12 months in 1998. The time then increased to about 14 months in 1999, fell back to 12 months in 2000, and rose again to about 14 months in 2001.

In comparison, the approval time for Priority Applications was about 16 months in 1994, dropped to 6 months in 1995, rose slightly in 1996, and then leveled out to about 6 months for 1997 through 2001

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