General discussion, page-5309

Approval times for 505(b) 2
The real time and cost saving for 505(b)(2) products comes from reduced development programs due to smaller and/or fewer studies rather than abbreviated review times.

505(b)(2) Products Approved in One Review Cycle

Of the applications approved via the 505(b)(2) regulatory pathway from 2009 – 2015, 64.5% were approved with only 1 review cycle. In some of these cases, preventable review delays occurred due to Refuse-To-File determinations, and the need to submit major amendments.