September 2011 Slide of the Month

Key Messages

• The overall median time for products approved after only review cycle (2001-2010) is 182 days for priority new active substances (NASs) and 304 days for standard NASs.
• The percentage of products approved after only one review cycle during 2001-2010 increased over the decade for both standards and priority NASs.

Methodology

• For each NAS, the approval time by year of approval was calculated as the time taken from the date an application is received by CDER to the date of Legal Marketing.
• Median approval time of NASs approved by CDER by one-cycle review was calculated according to priority designation.
• The percentage of NASs approved by CDER by one-cycle review was calculated according to  priority designation.

Source: CIRS Regulatory Review Times Database