Approval pathway not speeding up process, study shows

The 505(b)(2) approval pathway for New Drug Applications (NDAs) in the USA is not shortening approval times, according to an analysis conducted by research group the Tufts Center for the Study of Drug Development (CSDD).

This streamlined development process is aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, but it should not prompt companies filing NDAs to bring forward launch dates, the study suggests.

Joseph DiMasi, director of economic analysis at Tufts CSDD and principal investigator for the study, said: “While the 505(b)(2) regulatory pathway has been highly successful in bringing new therapies to market from 2009 through 2015, drug products approved under this pathway had a longer average approval time compared to new molecular entities approved during the same period.”